Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K-Number: K041511 · 2005-06-03

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

Device Summary

TRULENE NON-ABSORBABLE POLYPROPYLENE 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 K041511. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

TRULENE NON-ABSORBABLE POLYPROPYLENE 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 K041511.

When did TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE receive FDA 510(k) clearance?

TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE received FDA 510(k) clearance on 2005-06-03, under 510(k) number K041511.

Who is the listed applicant for TRULENE NON-ABSORBABLE POLYPROPYLENE 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 TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

The FDA product code for TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE is GAW.

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

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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.

↑