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FDA 510(k)

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC

K-Number: K021043 · 2002-06-21

ApplicantGramsmed, LLC
Decision Date2002-06-21
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC is the device name listed in this FDA 510(k) record. The listed applicant is Gramsmed, LLC. It received FDA 510(k) clearance on 2002-06-21 under 510(k) number K021043. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC?

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC is a medical device that received FDA 510(k) clearance on 2002-06-21. The listed applicant is Gramsmed, LLC. The 510(k) number is K021043.

When did GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC receive FDA 510(k) clearance?

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC received FDA 510(k) clearance on 2002-06-21, under 510(k) number K021043.

Who is the listed applicant for GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC?

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

What is the FDA product code for GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC?

The FDA product code for GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC is GAL.

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Other records listing Gramsmed, LLC 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.

K010672MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTUREK003017GRAMSORB SYNTHETIC ABSORBABLE SUTUREK003590GRAMS POLYESTER NONABSORBABLE SUTUREK002999GRAMS POLYPROPYLENE NONABSORBABLE SUTUREK003000GRAMS NYLON NONABSORBABLE SUTUREK003001GRAMS SILK NONABSORBABLE SUTURE

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Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K011105SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEQrc Consulting

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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