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FDA 510(k)

GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING

K-Number: K963175 · 1996-09-23

ApplicantGlycar, Inc.
Decision Date1996-09-23
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING is the device name listed in this FDA 510(k) record. The listed applicant is Glycar, Inc.. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K963175. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING?

GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Glycar, Inc.. The 510(k) number is K963175.

When did GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING receive FDA 510(k) clearance?

GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING received FDA 510(k) clearance on 1996-09-23, under 510(k) number K963175.

Who is the listed applicant for GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING?

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

What is the FDA product code for GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING?

The FDA product code for GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING is FTM.

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 Glycar, 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.

K963967GLYCAR PERICARDIAL PATCHK963368GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLEK954665GLYCAR STAPLE STRIPSK942911GLYCAR TISSUE REPAIR PATCH

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

Official Source

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

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