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FDA 510(k)

DEXON VIOLET

K-Number: K972566 · 1997-08-14

ApplicantDavis & Geck, Inc.
Decision Date1997-08-14
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEXON VIOLET 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 1997-08-14 under 510(k) number K972566. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXON VIOLET?

DEXON VIOLET is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K972566.

When did DEXON VIOLET receive FDA 510(k) clearance?

DEXON VIOLET received FDA 510(k) clearance on 1997-08-14, under 510(k) number K972566.

Who is the listed applicant for DEXON VIOLET?

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 VIOLET?

The FDA product code for DEXON VIOLET is GAM.

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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, & OPHTHALONK980610DEXON RAPID (DEXON R)K974015ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRALK980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICEK973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS

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Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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