Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FDA product code FCM · 60 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5130
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-10-07 – 2026-05-29
FCM
2026-05-29
FCM
2025-06-06
Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
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FCM
2023-08-02
Self-Cath Closed System
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FCM
2008-10-23
AMSELF CLOSED CATHETERIZATION SYSTEM
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FCM
2007-06-01
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
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FCM
2007-03-15
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
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FCM
2003-05-23
AMSURE URETHRAL CATHETERIZATION TRAY
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FCM
2003-05-23
AMSURE FOLEY INSERTION TRAY
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FCM
2001-06-06
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
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FCM
2001-05-09
RUSCH MMG/O'NEIL CATHETER
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FCM
2001-03-29
MENTOR SELF-CATH CLOSED SYSTEM
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FCM
2000-12-27
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
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FCM
1999-02-12
SELF CATH SET/SAFETY CATH
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FCM
1996-12-17
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
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FCM
1996-07-29
NHMC URETHRAL CATHETERIZATION TRAY
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FCM
1996-06-21
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
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FCM
1996-05-09
UNIVERSAL DRAINAGE TRAY
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FCM
1996-04-01
CPR URETHRAL CATHETER TRAY
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FCM
1996-04-01
CPR FOLEY CAHTETER KIT
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FCM
1996-02-29
NHMC FOLEY CATHETERIZATION TRAY
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FCM
1995-06-15
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
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FCM
1995-05-30
URETHRAL CATHETERIZATION TRAY
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FCM
1995-04-21
UROLOGICAL CATHETER & ACCESSORIES
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FCM
1995-03-24
HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER
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FCM
1995-02-27
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
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FCM
1995-02-27
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
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FCM
1994-09-08
FOLEY CATHETERIZATION TRAY
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FCM
1993-05-27
MON-A-THERM FOLEY KIT
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FCM
1991-05-06
TOUCHLESS II INTERMITTENT CATHETER
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FCM
1991-04-02
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
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FCM
1990-11-29
ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
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FCM
1990-10-04
STERILE URETHRAL CATHETER PROCEDURE KITS
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FCM
1990-08-23
LAKE MALE EXTERNAL CATHETERIZATION KIT
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FCM
1990-07-20
FOLEY CATHETER INSERTION TRAY (10CC)
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FCM
1990-07-20
URETHRAL CATHETER TRAY (LATEX)
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FCM
1990-07-20
URETHRAL CATHETER TRAY (PVC)
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FCM
1990-07-20
CATHETER CARE TRAY
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FCM
1990-07-20
FOLEY CATHETER INSERTION TRAY (30CC)
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FCM
1990-01-24
URETHRAL CATHETERIZATION TRAYS
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FCM
1979-04-10
FOLEY CATHETERIZATION TRAY
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FCM
1979-03-06
TRAY, URETHRAL CATHETERIZATION
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FCM
1979-03-06
TRAY AND BAG, CATHETERIZATION
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FCM
1978-07-31
URETHRO CATHETERIZATION TRAY
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FCM
1978-06-13
URINARY CATHETER CARE SET
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FCM
1978-03-02
BLADDER RETENTION-CATHETHERIZATIONTRAY
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FCM
1978-02-24
BLADDER CATH KIT W/OUT CATHETER
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FCM
1978-02-24
ROBINSON KIT - 750014 & 750016
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FCM
1978-02-24
BLADDER KIT - 734000
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FCM
1978-02-24
CATHETERIZATION KIT 732016-732018
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FCM
1978-02-21
CATHETERIZATION PROCED. TRAY, URETHRAL
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FCM
1978-02-21
CATHETERIZATION PROCEDURE TRAY
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FCM
1977-09-20
CATH-CARE TRAY
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FCM
1977-09-20
AKRO-SIL FOLEY KIT 5CC
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FCM
1977-09-20
AKRO-SIL FOLEY KIT 30CC
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FCM
1977-06-24
URETHRAL TRAY W/OUT CAHTETER, 7650
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FCM
1977-06-24
URETHRAL TRAY W/CATHETER, 7750
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FCM
1977-03-21
UNIVERSAL TRAY
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FCM
1977-03-01
TRAY, URETHRAL CATHETERIZATION
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FCM
1976-10-07
TRAY, CATHETERIZATION W/ CATHETER
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FCM
1976-10-07
TRAY, CATHETERIZATION W/O CATHETER
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