FDA 510(k)

PROSYS BEDSIDE DRAINAGE BAG

K-Number: K953767 · 1995-12-20

ApplicantConvatec, A Division of E.R. Squibb & Sons

Decision Date1995-12-20

Product CodeFAQ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PROSYS BEDSIDE DRAINAGE BAG 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 1995-12-20 under 510(k) number K953767. The device is classified under product code FAQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSYS BEDSIDE DRAINAGE BAG?

PROSYS BEDSIDE DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K953767.

When did PROSYS BEDSIDE DRAINAGE BAG receive FDA 510(k) clearance?

PROSYS BEDSIDE DRAINAGE BAG received FDA 510(k) clearance on 1995-12-20, under 510(k) number K953767.

Who is the listed applicant for PROSYS BEDSIDE DRAINAGE BAG?

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 BEDSIDE DRAINAGE BAG?

The FDA product code for PROSYS BEDSIDE DRAINAGE BAG is FAQ.

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

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Related Devices (Code: FAQ)

K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & Sons K960217CPR URINE BAGCustom Pack Reliability K955609CONVEEN URINE BAG - STERILEColoplast Corp.K953783CONVEEN LEG BAG STRAPColoplast Corp.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons K945204URINE COLLECTOR & ACCESSORIESNelmed 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.