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FDA 510(k)

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE

K-Number: K041510 · 2005-06-02

ApplicantSutures India Private Limited
Decision Date2005-06-02
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRULON NON-ABSORBABLE POLYAMIDE 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 2005-06-02 under 510(k) number K041510. 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 TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2005-06-02. The listed applicant is Sutures India Private Limited. The 510(k) number is K041510.

When did TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE receive FDA 510(k) clearance?

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE received FDA 510(k) clearance on 2005-06-02, under 510(k) number K041510.

Who is the listed applicant for TRULON NON-ABSORBABLE POLYAMIDE 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 TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE?

The FDA product code for TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE is GAR.

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.

K041514TRUESILK NON-ABSORBABLE SILK SURGICAL SUTUREK041511TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTUREK041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTUREK041515TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE

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

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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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