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FDA 510(k)

SURGILENE(R) SUTURES

K-Number: K945701 · 1995-01-24

ApplicantDavis & Geck, Inc.
Decision Date1995-01-24
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

SURGILENE(R) SUTURES 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 1995-01-24 under 510(k) number K945701. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SURGILENE(R) SUTURES?

SURGILENE(R) SUTURES is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K945701.

When did SURGILENE(R) SUTURES receive FDA 510(k) clearance?

SURGILENE(R) SUTURES received FDA 510(k) clearance on 1995-01-24, under 510(k) number K945701.

Who is the listed applicant for SURGILENE(R) SUTURES?

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 SURGILENE(R) SUTURES?

The FDA product code for SURGILENE(R) SUTURES is GAW.

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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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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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