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FDA 510(k)

SUR-FIT UROSTOMY POUCH W/ACCUSEAL

K-Number: K840166 · 1984-02-04

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1984-02-04
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUR-FIT UROSTOMY POUCH W/ACCUSEAL 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 1984-02-04 under 510(k) number K840166. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUR-FIT UROSTOMY POUCH W/ACCUSEAL?

SUR-FIT UROSTOMY POUCH W/ACCUSEAL is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K840166.

When did SUR-FIT UROSTOMY POUCH W/ACCUSEAL receive FDA 510(k) clearance?

SUR-FIT UROSTOMY POUCH W/ACCUSEAL received FDA 510(k) clearance on 1984-02-04, under 510(k) number K840166.

Who is the listed applicant for SUR-FIT UROSTOMY POUCH W/ACCUSEAL?

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 SUR-FIT UROSTOMY POUCH W/ACCUSEAL?

The FDA product code for SUR-FIT UROSTOMY POUCH W/ACCUSEAL is EXB.

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

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Related Devices (Code: EXB)

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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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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