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FDA 510(k)

PERMACOL SURGICAL IMPLANT

K-Number: K043366 · 2004-12-17

ApplicantTissue Science Laboratories, Plc
Decision Date2004-12-17
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERMACOL SURGICAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Science Laboratories, Plc. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K043366. 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 PERMACOL SURGICAL IMPLANT?

PERMACOL SURGICAL IMPLANT is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Tissue Science Laboratories, Plc. The 510(k) number is K043366.

When did PERMACOL SURGICAL IMPLANT receive FDA 510(k) clearance?

PERMACOL SURGICAL IMPLANT received FDA 510(k) clearance on 2004-12-17, under 510(k) number K043366.

Who is the listed applicant for PERMACOL SURGICAL IMPLANT?

The FDA 510(k) record lists Tissue Science Laboratories, Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERMACOL SURGICAL IMPLANT?

The FDA product code for PERMACOL SURGICAL IMPLANT 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 Tissue Science Laboratories, Plc 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.

K053562ZIMMER COLLAGEN REPAIR PATCHK050355PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150K021056PERMACOLK013625PERMACOLK992556PERMACOL

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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