FDA 510(k)

STERILE URETHRAL CATHETER PROCEDURE KITS

K-Number: K903340 · 1990-10-04

ApplicantSuperior Healthcare Group, Inc.

Decision Date1990-10-04

Product CodeFCM

Advisory CommitteeGU

DecisionUnknown

Device Summary

STERILE URETHRAL CATHETER PROCEDURE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Superior Healthcare Group, Inc.. It received FDA 510(k) clearance on 1990-10-04 under 510(k) number K903340. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STERILE URETHRAL CATHETER PROCEDURE KITS?

STERILE URETHRAL CATHETER PROCEDURE KITS is a medical device that received FDA 510(k) clearance on 1990-10-04. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K903340.

When did STERILE URETHRAL CATHETER PROCEDURE KITS receive FDA 510(k) clearance?

STERILE URETHRAL CATHETER PROCEDURE KITS received FDA 510(k) clearance on 1990-10-04, under 510(k) number K903340.

Who is the listed applicant for STERILE URETHRAL CATHETER PROCEDURE KITS?

The FDA 510(k) record lists Superior Healthcare Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE URETHRAL CATHETER PROCEDURE KITS?

The FDA product code for STERILE URETHRAL CATHETER PROCEDURE KITS is FCM.

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Other records listing Superior Healthcare Group, Inc. as applicant

K925530INSTRUMENT WARMER K924764OVERTUBE FOR ENDSCOPIC LIGATOR K905755NON-STERILE PATIENT EXAMINATION GLOVES K903347SODIUM CHLORIDE SOLUTION K904216STERILE WATER SOLUTION CATALOG # 10000 K896321NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.

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Related Devices (Code: FCM)

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure 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 (CS14CConvatec Limited K223821Self-Cath Closed SystemColoplast K082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLC K070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.