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FDA 510(k)

CATHETER WITHDRAWAL UNIT

K-Number: K881878 · 1988-07-28

ApplicantEris Medical Technology
Decision Date1988-07-28
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER WITHDRAWAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Eris Medical Technology. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K881878. 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 CATHETER WITHDRAWAL UNIT?

CATHETER WITHDRAWAL UNIT is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Eris Medical Technology. The 510(k) number is K881878.

When did CATHETER WITHDRAWAL UNIT receive FDA 510(k) clearance?

CATHETER WITHDRAWAL UNIT received FDA 510(k) clearance on 1988-07-28, under 510(k) number K881878.

Who is the listed applicant for CATHETER WITHDRAWAL UNIT?

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

What is the FDA product code for CATHETER WITHDRAWAL UNIT?

The FDA product code for CATHETER WITHDRAWAL UNIT is KNY.

Related Clinical Trials

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.

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Other records listing Eris Medical Technology 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.

K882295FILLING VOLUME OPTIONK850169ERIS URO-DIAGNOSTIC SYSTEM

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

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

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