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Oxiplex FPC-09020

by FzioMed, Inc.

Oxiplex FPC-09020 is a Class II device made by FzioMed, Inc., cleared under FDA 510(k) K253326 on 1 May 2026 and listed in FDA GUDID since 15 Jun 2026 (UDI-DI 00854395004514), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K253326

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854395004514 UDI-DI Date15 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK253326 Date1 May 2026IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253326 decided 1 May 2026 Active
  • FDA GUDID UDI-DI 00854395004514 listed 15 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253326
  2. Listed FDA GUDID 00854395004514

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Oxiplex
Generic name
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Model / reference
FPC-09020
Primary DI / UDI-DI
00854395004514
510(k) Number
FDA product code
QVL
GMDN term
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Device class
Class II
Regulation number
888.3047
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Total Volume — 1.5 Milliliter

Other devices from FzioMed, Inc.

See all devices from FzioMed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)