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)

SUTULENE

K-Number: K943220 · 1994-12-05

ApplicantSutures , Ltd.
Decision Date1994-12-05
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

SUTULENE is the device name listed in this FDA 510(k) record. The listed applicant is Sutures , Ltd.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K943220. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SUTULENE?

SUTULENE is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Sutures , Ltd.. The 510(k) number is K943220.

When did SUTULENE receive FDA 510(k) clearance?

SUTULENE received FDA 510(k) clearance on 1994-12-05, under 510(k) number K943220.

Who is the listed applicant for SUTULENE?

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

What is the FDA product code for SUTULENE?

The FDA product code for SUTULENE is GAT.

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 , Ltd. 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.

K990432SURGISORBK953609PRODEKK943223SURGIDEK BK943217PLAIN CATGUTK943218CHROMIC CATGUTK943627SURGISILK

View all 11 devices →

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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.

↑