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FDA 510(k)

ACM PTFE SURGICAL MESH

K-Number: K944413 · 1994-11-09

ApplicantAmerican Custom Medical, Inc.
Decision Date1994-11-09
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACM PTFE SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is American Custom Medical, Inc.. It received FDA 510(k) clearance on 1994-11-09 under 510(k) number K944413. 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 ACM PTFE SURGICAL MESH?

ACM PTFE SURGICAL MESH is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is American Custom Medical, Inc.. The 510(k) number is K944413.

When did ACM PTFE SURGICAL MESH receive FDA 510(k) clearance?

ACM PTFE SURGICAL MESH received FDA 510(k) clearance on 1994-11-09, under 510(k) number K944413.

Who is the listed applicant for ACM PTFE SURGICAL MESH?

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

What is the FDA product code for ACM PTFE SURGICAL MESH?

The FDA product code for ACM PTFE SURGICAL MESH 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.

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Other records listing American Custom Medical, 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.

K965205TEFGEN - LSK964656TEFGEN GUIDED TISSUE MEMBRANEK935137TEFGEN-FDK933800FLUOROFILM(R)

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

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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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