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FDA 510(k)

KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET

K-Number: K970969 · 1997-04-23

ApplicantThe Kendal Co.
Decision Date1997-04-23
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET is the device name listed in this FDA 510(k) record. The listed applicant is The Kendal Co.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K970969. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET?

KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is The Kendal Co.. The 510(k) number is K970969.

When did KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET receive FDA 510(k) clearance?

KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET received FDA 510(k) clearance on 1997-04-23, under 510(k) number K970969.

Who is the listed applicant for KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET?

The FDA 510(k) record lists The Kendal Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET?

The FDA product code for KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET is KOB.

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Other records listing The Kendal Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000087MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FRK990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CK991758MONOJECT INSULIN SYRINGEK951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPK942664KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEMK942774POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING

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Related Devices (Code: KOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.

Official Source

View on FDA Database →

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

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