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FDA 510(k)

WOUND MANAGER(TM) - STERILE

K-Number: K862935 · 1986-08-20

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1986-08-20
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

WOUND MANAGER(TM) - STERILE 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 1986-08-20 under 510(k) number K862935. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the WOUND MANAGER(TM) - STERILE?

WOUND MANAGER(TM) - STERILE is a medical device that received FDA 510(k) clearance on 1986-08-20. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K862935.

When did WOUND MANAGER(TM) - STERILE receive FDA 510(k) clearance?

WOUND MANAGER(TM) - STERILE received FDA 510(k) clearance on 1986-08-20, under 510(k) number K862935.

Who is the listed applicant for WOUND MANAGER(TM) - STERILE?

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 WOUND MANAGER(TM) - STERILE?

The FDA product code for WOUND MANAGER(TM) - STERILE is NAD.

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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.

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Related Devices (Code: NAD)

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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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