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)

SURGISTEEL

K-Number: K865038 · 1987-06-30

ApplicantSutures , Ltd.
Decision Date1987-06-30
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISTEEL is the device name listed in this FDA 510(k) record. The listed applicant is Sutures , Ltd.. It received FDA 510(k) clearance on 1987-06-30 under 510(k) number K865038. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGISTEEL?

SURGISTEEL is a medical device that received FDA 510(k) clearance on 1987-06-30. The listed applicant is Sutures , Ltd.. The 510(k) number is K865038.

When did SURGISTEEL receive FDA 510(k) clearance?

SURGISTEEL received FDA 510(k) clearance on 1987-06-30, under 510(k) number K865038.

Who is the listed applicant for SURGISTEEL?

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 SURGISTEEL?

The FDA product code for SURGISTEEL is GAQ.

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.

K990432SURGISORBK953609PRODEKK943217PLAIN CATGUTK943218CHROMIC CATGUTK943222SURGIDEK SK943221SURGIBOND

View all 11 devices →

Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLCK082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated

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.

↑