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FDA 510(k)

SUTURE FIXATION DEVICE; MESH FIXATION DEVICE

K-Number: K021834 · 2002-08-28

ApplicantMle, Inc.
Decision Date2002-08-28
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE FIXATION DEVICE; MESH FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mle, Inc.. It received FDA 510(k) clearance on 2002-08-28 under 510(k) number K021834. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE FIXATION DEVICE; MESH FIXATION DEVICE?

SUTURE FIXATION DEVICE; MESH FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2002-08-28. The listed applicant is Mle, Inc.. The 510(k) number is K021834.

When did SUTURE FIXATION DEVICE; MESH FIXATION DEVICE receive FDA 510(k) clearance?

SUTURE FIXATION DEVICE; MESH FIXATION DEVICE received FDA 510(k) clearance on 2002-08-28, under 510(k) number K021834.

Who is the listed applicant for SUTURE FIXATION DEVICE; MESH FIXATION DEVICE?

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

What is the FDA product code for SUTURE FIXATION DEVICE; MESH FIXATION DEVICE?

The FDA product code for SUTURE FIXATION DEVICE; MESH FIXATION DEVICE is GAW.

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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