SwitchPoint Infinity, iSuite 0678003000

by STRYKER Communications, Inc.

SwitchPoint Infinity, iSuite 0678003000 (0678-003-000) 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 23 Sep 2016 (UDI-DI 07613327054255), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07613327054255 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK100852	Date6 May 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07613327054255
FDA 510(k) database 510(k) number K100852

Across registries

2 registries list this device

FDA 510(k) K100852 decided 6 May 2010 Active
FDA GUDID UDI-DI 07613327054255 listed 23 Sep 2016 Listed

Timeline

2 dated events

6 May 2010 Cleared FDA 510(k) K100852
23 Sep 2016 Listed FDA GUDID 07613327054255

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: SwitchPoint Infinity, iSuite
Generic name: Operating room audiovisual data/device management system
Model / Ref / Catalog: 0678003000, 0678-003-000

Primary DI / UDI-DI: 07613327054255
510(k) Number: K100852
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

Other devices from STRYKER Communications, Inc.

See all devices from STRYKER Communications, Inc. →

Properties

Prescription use
Serial number

Other properties (13, all answered No)