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FDA 510(k)

GRAMS POLYESTER NONABSORBABLE SUTURE

K-Number: K003590 · 2001-03-05

ApplicantGramsmed, LLC
Decision Date2001-03-05
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAMS POLYESTER NONABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Gramsmed, LLC. It received FDA 510(k) clearance on 2001-03-05 under 510(k) number K003590. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAMS POLYESTER NONABSORBABLE SUTURE?

GRAMS POLYESTER NONABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2001-03-05. The listed applicant is Gramsmed, LLC. The 510(k) number is K003590.

When did GRAMS POLYESTER NONABSORBABLE SUTURE receive FDA 510(k) clearance?

GRAMS POLYESTER NONABSORBABLE SUTURE received FDA 510(k) clearance on 2001-03-05, under 510(k) number K003590.

Who is the listed applicant for GRAMS POLYESTER NONABSORBABLE SUTURE?

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 POLYESTER NONABSORBABLE SUTURE?

The FDA product code for GRAMS POLYESTER NONABSORBABLE SUTURE is GAT.

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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.

K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICK010672MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTUREK003017GRAMSORB SYNTHETIC ABSORBABLE SUTUREK002999GRAMS POLYPROPYLENE NONABSORBABLE SUTUREK003000GRAMS NYLON NONABSORBABLE SUTUREK003001GRAMS SILK NONABSORBABLE SUTURE

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Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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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