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FDA 510(k)

SUTURE NON-ABSORBABLE SILK

K-Number: K931913 · 1994-03-03

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

Device Summary

SUTURE NON-ABSORBABLE SILK 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 K931913. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE NON-ABSORBABLE SILK?

SUTURE NON-ABSORBABLE SILK 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 K931913.

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

SUTURE NON-ABSORBABLE SILK received FDA 510(k) clearance on 1994-03-03, under 510(k) number K931913.

Who is the listed applicant for SUTURE NON-ABSORBABLE SILK?

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 SILK?

The FDA product code for SUTURE NON-ABSORBABLE SILK is GAP.

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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 PLAINK931916SUTURE NON-ABSORBABLE SYNTHETIC POLYESTERK931915STAINLESS STEEL SUTUREK931917SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENEK931919CATGUT SUTURE CHROMIC

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Related Devices (Code: GAP)

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.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.

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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