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FDA 510(k)

DEXON DISSECTING SPONGE

K-Number: K914365 · 1991-10-23

ApplicantDavis & Geck, Inc.
Decision Date1991-10-23
Product CodeGAK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEXON DISSECTING SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Davis & Geck, Inc.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K914365. The device is classified under product code GAK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXON DISSECTING SPONGE?

DEXON DISSECTING SPONGE is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K914365.

When did DEXON DISSECTING SPONGE receive FDA 510(k) clearance?

DEXON DISSECTING SPONGE received FDA 510(k) clearance on 1991-10-23, under 510(k) number K914365.

Who is the listed applicant for DEXON DISSECTING SPONGE?

The FDA 510(k) record lists Davis & Geck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXON DISSECTING SPONGE?

The FDA product code for DEXON DISSECTING SPONGE is GAK.

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Other records listing Davis & Geck, Inc. 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.

K982853SILK SUTUREK981582SURGILON, DERMALON, & OPHTHALONK974015ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRALK980610DEXON RAPID (DEXON R)K980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICEK973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS

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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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