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FDA 510(k)

ADVANCE SUTURE ABSORBABLE GUT SUTURE

K-Number: K903174 · 1991-07-10

ApplicantAdvance Suture, Inc.
Decision Date1991-07-10
Product CodeGAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADVANCE SUTURE ABSORBABLE GUT SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Advance Suture, Inc.. It received FDA 510(k) clearance on 1991-07-10 under 510(k) number K903174. The device is classified under product code GAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE SUTURE ABSORBABLE GUT SUTURE?

ADVANCE SUTURE ABSORBABLE GUT SUTURE is a medical device that received FDA 510(k) clearance on 1991-07-10. The listed applicant is Advance Suture, Inc.. The 510(k) number is K903174.

When did ADVANCE SUTURE ABSORBABLE GUT SUTURE receive FDA 510(k) clearance?

ADVANCE SUTURE ABSORBABLE GUT SUTURE received FDA 510(k) clearance on 1991-07-10, under 510(k) number K903174.

Who is the listed applicant for ADVANCE SUTURE ABSORBABLE GUT SUTURE?

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

What is the FDA product code for ADVANCE SUTURE ABSORBABLE GUT SUTURE?

The FDA product code for ADVANCE SUTURE ABSORBABLE GUT SUTURE is GAE.

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 Advance Suture, Inc. 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.

K903175ADVANCE SUTURE NONABSORBABLE DACRON SUTUREK903177ADVANCE SUTURE NONABSORBABLE NYLON SUTUREK903176ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTUREK905454ADVANCE SUTURE NONABSORBABLE SILK SUTURE

Related Devices (Code: GAE)

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.

K950776BIPOLAR SNARECook Urological, Inc.K926036ACUFEX SUTURE RETRIEVERAcufex Microsurgical, Inc.K881224ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLEAcufex Microsurgical, 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.

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