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FDA 510(k)

SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER

K-Number: K931916 · 1994-03-03

ApplicantSurgimetrics International, Ltd.
Decision Date1994-03-03
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER is the device name listed in this FDA 510(k) record. The listed applicant is Surgimetrics International, Ltd.. It received FDA 510(k) clearance on 1994-03-03 under 510(k) number K931916. 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 SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER?

SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER is a medical device that received FDA 510(k) clearance on 1994-03-03. The listed applicant is Surgimetrics International, Ltd.. The 510(k) number is K931916.

When did SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER receive FDA 510(k) clearance?

SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER received FDA 510(k) clearance on 1994-03-03, under 510(k) number K931916.

Who is the listed applicant for SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER?

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

What is the FDA product code for SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER?

The FDA product code for SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER is GAT.

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Other records listing Surgimetrics International, Ltd. 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.

K931914SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDEK931918CATGUT SUTURE PLAINK931913SUTURE NON-ABSORBABLE SILKK931915STAINLESS STEEL SUTUREK931917SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENEK931919CATGUT SUTURE CHROMIC

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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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