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Avanos 44735

by Avanos Medical, Inc.

Avanos 44735 (MB500) is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K162048 on 5 Dec 2016 and listed in FDA GUDID since 7 May 2020 (UDI-DI 00193494447359), 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) K162048

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 Number00193494447359 UDI-DI Date7 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162048 Date5 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162048 decided 5 Dec 2016 Active
  • FDA GUDID UDI-DI 00193494447359 listed 7 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162048
  2. Listed FDA GUDID 00193494447359

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  • Withdrawn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
Nerve-locating system
Model / Ref / Catalog
44735, MB500
Primary DI / UDI-DI
00193494447359
510(k) Number
FDA product code
KOI
GMDN term
Nerve-locating system
Device class
Class II
Regulation number
868.2775
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nerve-locating system

Cleared under the same submission (K162048)

and 1 more cleared under K162048

Similar devices

Other devices filed under FDA product code KOI (STIMULATOR, NERVE, PERIPHERAL, ELECTRIC).

Other devices from Avanos Medical, Inc.

See all devices from Avanos Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)