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FDA 510(k)

SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE

K-Number: K931914 · 1994-10-05

ApplicantSurgimetrics International, Ltd.
Decision Date1994-10-05
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE 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 1994-10-05 under 510(k) number K931914. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE?

SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE is a medical device that received FDA 510(k) clearance on 1994-10-05. The listed applicant is Surgimetrics International, Ltd.. The 510(k) number is K931914.

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

SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE received FDA 510(k) clearance on 1994-10-05, under 510(k) number K931914.

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

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 POLYLMIDE?

The FDA product code for SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE is GAR.

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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.

K931918CATGUT SUTURE PLAINK931916SUTURE NON-ABSORBABLE SYNTHETIC POLYESTERK931913SUTURE NON-ABSORBABLE SILKK931915STAINLESS STEEL SUTUREK931917SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENEK931919CATGUT SUTURE CHROMIC

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Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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