Skip to content

0101-0001

by Stryker GmbH

0101-0001 is a Class II device made by Stryker GmbH, cleared under FDA 510(k) K173946 on 2 May 2018 and listed in FDA GUDID since 14 Sep 2018 (UDI-DI 07613327311822), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K173946

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327311822 UDI-DI Date14 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173946 Date2 May 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173946 decided 2 May 2018 Active
  • FDA GUDID UDI-DI 07613327311822 listed 14 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173946
  2. Listed FDA GUDID 07613327311822

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Medical image management system
Model / Ref / Catalog
0101-0001
Primary DI / UDI-DI
07613327311822
FDA product code
OLO
GMDN term
Medical image management system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical image management system

Cleared under the same submission (K173946)

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)