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FDA 510(k)

PROSYS URIHESICE SYSTEM NL

K-Number: K950690 · 1995-03-23

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1995-03-23
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROSYS URIHESICE SYSTEM NL 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 1995-03-23 under 510(k) number K950690. The device is classified under product code EXJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSYS URIHESICE SYSTEM NL?

PROSYS URIHESICE SYSTEM NL is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K950690.

When did PROSYS URIHESICE SYSTEM NL receive FDA 510(k) clearance?

PROSYS URIHESICE SYSTEM NL received FDA 510(k) clearance on 1995-03-23, under 510(k) number K950690.

Who is the listed applicant for PROSYS URIHESICE SYSTEM NL?

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 PROSYS URIHESICE SYSTEM NL?

The FDA product code for PROSYS URIHESICE SYSTEM NL is EXJ.

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

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Related Devices (Code: EXJ)

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.

K970465BOUSER'S URINALGeneral PolymersK972100VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)Advanced Care Medical ProductsK970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERSierra Laboratories, Inc.K963265PROSYS SAMEC LAConvatec, A Division of E.R. Squibb & SonsK962900SELF RETAINING MALE EXTERNAL URINARY CATHETERHollister, Inc.K962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERSierra Laboratories, Inc.

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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