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FDA 510(k)

STAINLESS STEEL SUTURE

K-Number: K931915 · 1994-03-03

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

Device Summary

STAINLESS STEEL SUTURE 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 K931915. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAINLESS STEEL SUTURE?

STAINLESS STEEL SUTURE 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 K931915.

When did STAINLESS STEEL SUTURE receive FDA 510(k) clearance?

STAINLESS STEEL SUTURE received FDA 510(k) clearance on 1994-03-03, under 510(k) number K931915.

Who is the listed applicant for STAINLESS STEEL SUTURE?

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 STAINLESS STEEL SUTURE?

The FDA product code for STAINLESS STEEL SUTURE is GAQ.

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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 POLYESTERK931913SUTURE NON-ABSORBABLE SILKK931917SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENEK931919CATGUT SUTURE CHROMIC

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Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLCK082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated

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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