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Avanos Pma-Bp

by Avanos Medical, Inc.

Avanos Pma-Bp is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K002389 on 23 Oct 2000 and listed in FDA GUDID since 10 Aug 2020 (UDI-DI 00193493985951), active as of 23 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 23 Oct 2026

Documents

510(k) K002389

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00193493985951 UDI-DI Date10 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002389 Date23 Oct 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002389 decided 23 Oct 2000 Active
  • FDA GUDID UDI-DI 00193493985951 listed 10 Aug 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K002389
  2. Listed FDA GUDID 00193493985951

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Avanos
Generic name
Electrosurgical cable adaptor
Model / Ref / Catalog
PMA-BP
Primary DI / UDI-DI
00193493985951
510(k) Number
FDA product code
GXI
GMDN term
Electrosurgical cable adaptor
Device class
Class II
Regulation number
882.4725
GUDID distribution status
In Commercial Distribution

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Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)