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FDA 510(k)

FLEXI-TRAK ANCHORING DEVICE

K-Number: K932143 · 1993-12-01

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1993-12-01
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXI-TRAK ANCHORING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1993-12-01 under 510(k) number K932143. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXI-TRAK ANCHORING DEVICE?

FLEXI-TRAK ANCHORING DEVICE is a medical device that received FDA 510(k) clearance on 1993-12-01. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K932143.

When did FLEXI-TRAK ANCHORING DEVICE receive FDA 510(k) clearance?

FLEXI-TRAK ANCHORING DEVICE received FDA 510(k) clearance on 1993-12-01, under 510(k) number K932143.

Who is the listed applicant for FLEXI-TRAK ANCHORING DEVICE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXI-TRAK ANCHORING DEVICE?

The FDA product code for FLEXI-TRAK ANCHORING DEVICE is KNY.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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