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FDA 510(k)

BAG, DRAINAGEW/ADHESIVE; PROSTHESIS

K-Number: K772366 · 1978-01-26

ApplicantAtlantic Surgical
Decision Date1978-01-26
Product CodeFON
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAG, DRAINAGEW/ADHESIVE; PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Surgical. It received FDA 510(k) clearance on 1978-01-26 under 510(k) number K772366. The device is classified under product code FON. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAG, DRAINAGEW/ADHESIVE; PROSTHESIS?

BAG, DRAINAGEW/ADHESIVE; PROSTHESIS is a medical device that received FDA 510(k) clearance on 1978-01-26. The listed applicant is Atlantic Surgical. The 510(k) number is K772366.

When did BAG, DRAINAGEW/ADHESIVE; PROSTHESIS receive FDA 510(k) clearance?

BAG, DRAINAGEW/ADHESIVE; PROSTHESIS received FDA 510(k) clearance on 1978-01-26, under 510(k) number K772366.

Who is the listed applicant for BAG, DRAINAGEW/ADHESIVE; PROSTHESIS?

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

What is the FDA product code for BAG, DRAINAGEW/ADHESIVE; PROSTHESIS?

The FDA product code for BAG, DRAINAGEW/ADHESIVE; PROSTHESIS is FON.

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Other records listing Atlantic Surgical 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.

K820167LAMINATED KARAYA GUM WASHERSK770230KARAYA GUM POWDER

Related Devices (Code: FON)

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.

K801504HOLLISTER DRAINAGE POUCHHollister, Inc.K770826POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITEHowmedica 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.

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