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FDA 510(k)

GLYCAR TISSUE REPAIR PATCH

K-Number: K942911 · 1994-12-14

ApplicantGlycar, Inc.
Decision Date1994-12-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GLYCAR TISSUE REPAIR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Glycar, Inc.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K942911. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCAR TISSUE REPAIR PATCH?

GLYCAR TISSUE REPAIR PATCH is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Glycar, Inc.. The 510(k) number is K942911.

When did GLYCAR TISSUE REPAIR PATCH receive FDA 510(k) clearance?

GLYCAR TISSUE REPAIR PATCH received FDA 510(k) clearance on 1994-12-14, under 510(k) number K942911.

Who is the listed applicant for GLYCAR TISSUE REPAIR PATCH?

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?

The FDA product code for GLYCAR TISSUE REPAIR PATCH is FTL.

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 POSSIBLEK963175GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLINGK954665GLYCAR STAPLE STRIPS

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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