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Wireless Receiver Uwit-Rx

by Olympus Medical Systems Corporation

Wireless Receiver Uwit-Rx, a medical networking interface unit (FDA Class II; FDA product code GCJ, Laparoscope, general & plastic surgery) made by Olympus Medical Systems Corporation, was cleared under FDA 510(k) K120278 on 10 Aug 2012 and listed in FDA GUDID on 21 Sep 2016 (UDI-DI 04953170327711); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K120278

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 Number04953170327711 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120278 Date10 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120278 decided 10 Aug 2012 Active
  • FDA GUDID UDI-DI 04953170327711 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120278
  2. Listed FDA GUDID 04953170327711

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wireless Receiver
Generic name
Medical networking interface unit
Model / reference
UWIT-RX
Primary DI / UDI-DI
04953170327711
510(k) Number
FDA product code
GCJ
GMDN term
Medical networking interface unit
Device class
Class II
Regulation number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K120278)

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, general & plastic surgery).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)