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)

ORLON NONABSORABLE SURGICAL SUTURE USP

K-Number: K030177 · 2003-07-21

ApplicantSri Orion Pharmaceuticals & Sutures
Decision Date2003-07-21
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORLON NONABSORABLE SURGICAL SUTURE USP is the device name listed in this FDA 510(k) record. The listed applicant is Sri Orion Pharmaceuticals & Sutures. It received FDA 510(k) clearance on 2003-07-21 under 510(k) number K030177. 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 ORLON NONABSORABLE SURGICAL SUTURE USP?

ORLON NONABSORABLE SURGICAL SUTURE USP is a medical device that received FDA 510(k) clearance on 2003-07-21. The listed applicant is Sri Orion Pharmaceuticals & Sutures. The 510(k) number is K030177.

When did ORLON NONABSORABLE SURGICAL SUTURE USP receive FDA 510(k) clearance?

ORLON NONABSORABLE SURGICAL SUTURE USP received FDA 510(k) clearance on 2003-07-21, under 510(k) number K030177.

Who is the listed applicant for ORLON NONABSORABLE SURGICAL SUTURE USP?

The FDA 510(k) record lists Sri Orion Pharmaceuticals & Sutures as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORLON NONABSORABLE SURGICAL SUTURE USP?

The FDA product code for ORLON NONABSORABLE SURGICAL SUTURE USP 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

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

View on FDA Database →

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

↑