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Safyre VS and Safyre T

by Promedon

510(k) K033691

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK033691 Date19 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OTN
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Safyre VS and Safyre T is a synthetic surgical mesh device used for the treatment of stress urinary incontinence via retropubic or transobturator approaches. It is classified as a urogynecologic mesh implant intended for use in female pelvic floor reconstruction.

The device is supplied as a sterile, single-use implant and is indicated for use in general and plastic surgery settings. It received FDA 510(k) clearance under K033691 and is regulated as a Class II medical device with product code OTN.

Other devices from Promedon

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Safyre VS and Safyre T used for?

    The Safyre VS and Safyre T is a synthetic surgical mesh device used for the treatment of stress urinary incontinence via retropubic or transobturator approaches. It is indicated for female pelvic floor reconstruction in general and plastic surgery settings, providing support to the urethra and bladder neck to reduce involuntary urine leakage during physical activity.

  • How is the Safyre VS and Safyre T supplied and is it reusable?

    The Safyre VS and Safyre T is supplied as a sterile, single-use implant. It is intended for one-time use only and must not be reprocessed or reused, as doing so could compromise sterility, structural integrity, and patient safety, increasing the risk of infection or device failure.

  • What regulatory pathway was used for the Safyre VS and Safyre T?

    The Safyre VS and Safyre T received FDA 510(k) clearance under submission number K033691, demonstrating substantial equivalence to a legally marketed predicate device. It is regulated as a Class II medical device with product code OTN, which corresponds to synthetic urogynecologic mesh for stress urinary incontinence.