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Switchpoint Infinity 0678001400

by STRYKER Communications, Inc.

Switchpoint Infinity 0678001400 (0678-001-400) is a Class II device made by STRYKER Communications, Inc., cleared under FDA 510(k) K100852 on 6 May 2010 and listed in FDA GUDID since 7 Nov 2016 (UDI-DI 07613327303605), 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) K100852

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 Number07613327303605 UDI-DI Date7 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100852 Date6 May 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100852 decided 6 May 2010 Active
  • FDA GUDID UDI-DI 07613327303605 listed 7 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100852
  2. Listed FDA GUDID 07613327303605

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Switchpoint Infinity
Generic name
Operating room audiovisual data/device management system
Model / Ref / Catalog
0678001400, 0678-001-400
Primary DI / UDI-DI
07613327303605
510(k) Number
FDA product code
OCS
GMDN term
Operating room audiovisual data/device management system
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Operating room audiovisual data/device management system

Cleared under the same submission (K100852)

Other devices from STRYKER Communications, Inc.

See all devices from STRYKER Communications, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)