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FDA 510(k)

TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE

K-Number: K041514 · 2005-06-03

ApplicantSutures India Private Limited
Decision Date2005-06-03
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Sutures India Private Limited. It received FDA 510(k) clearance on 2005-06-03 under 510(k) number K041514. 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 TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE?

TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2005-06-03. The listed applicant is Sutures India Private Limited. The 510(k) number is K041514.

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

TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE received FDA 510(k) clearance on 2005-06-03, under 510(k) number K041514.

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

The FDA 510(k) record lists Sutures India Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE?

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sutures India Private Limited 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.

K041511TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTUREK041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTUREK041510TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTUREK041515TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE

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

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

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