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FDA 510(k)

SUPRAMESH EXTRA

K-Number: K080216 · 2008-09-15

ApplicantS. Jackson, Inc.
Decision Date2008-09-15
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPRAMESH EXTRA is the device name listed in this FDA 510(k) record. The listed applicant is S. Jackson, Inc.. It received FDA 510(k) clearance on 2008-09-15 under 510(k) number K080216. 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 SUPRAMESH EXTRA?

SUPRAMESH EXTRA is a medical device that received FDA 510(k) clearance on 2008-09-15. The listed applicant is S. Jackson, Inc.. The 510(k) number is K080216.

When did SUPRAMESH EXTRA receive FDA 510(k) clearance?

SUPRAMESH EXTRA received FDA 510(k) clearance on 2008-09-15, under 510(k) number K080216.

Who is the listed applicant for SUPRAMESH EXTRA?

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

What is the FDA product code for SUPRAMESH EXTRA?

The FDA product code for SUPRAMESH EXTRA is FTL.

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Other records listing S. Jackson, 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.

K973379STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETSK931614MOPYLEN SUTUREK931613SUPRAMID SUTUREK931612NYLAMID SUTUREK922630MOPYLENK912429N80-838 SUPRAMID EXTRA SUTURE

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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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