FDA 510(k)

IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES

K-Number: K905287 · 1991-02-11

ApplicantInternacional Farmaceutica, S.A. DE C.V.

Decision Date1991-02-11

Product CodeGAP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES is the device name listed in this FDA 510(k) record. The listed applicant is Internacional Farmaceutica, S.A. DE C.V.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905287. 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 IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES?

IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Internacional Farmaceutica, S.A. DE C.V.. The 510(k) number is K905287.

When did IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES receive FDA 510(k) clearance?

IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905287.

Who is the listed applicant for IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES?

The FDA 510(k) record lists Internacional Farmaceutica, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES?

The FDA product code for IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES is GAP.

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Other records listing Internacional Farmaceutica, S.A. DE C.V. as applicant

K072863ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES K072859ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES K041048POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE K040282ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID K913185STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT K911354STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES

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Related Devices (Code: GAP)

K241486Sofsilk™ Coated Braided Silk SutureCovidien K222944SafePath 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.