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FDA 510(k)

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH

K-Number: K002721 · 2000-11-29

ApplicantAmerican Medical Systems, Inc.
Decision Date2000-11-29
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-11-29 under 510(k) number K002721. 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 AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH?

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K002721.

When did AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH receive FDA 510(k) clearance?

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH received FDA 510(k) clearance on 2000-11-29, under 510(k) number K002721.

Who is the listed applicant for AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH?

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

What is the FDA product code for AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH?

The FDA product code for AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH is FTL.

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Other records listing American Medical Systems, Inc. as applicant

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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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