BF402

by Steris Corporation

BF402 is a universal operating table top (FDA Class I; FDA product code FQO, Table, Operating-Room, Ac-Powered) made by Steris Corporation, cleared under FDA 510(k) K971307 on 27 Jun 1997 and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00724995164508), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00724995164508 UDI-DI	Date23 Apr 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK971307	Date27 Jun 1997Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00724995164508
FDA 510(k) database 510(k) number K971307

Across registries

2 registries list this device

FDA 510(k) K971307 decided 27 Jun 1997 Active
FDA GUDID UDI-DI 00724995164508 listed 23 Apr 2021 Listed

Timeline

2 dated events

27 Jun 1997 Cleared FDA 510(k) K971307
23 Apr 2021 Listed FDA GUDID 00724995164508

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Universal operating table top
Model / Ref / Catalog: BF402

Primary DI / UDI-DI: 00724995164508
510(k) Number: K971307
FDA product code: FQO
GMDN term: Universal operating table top

Device class: Class I
Regulation number: 878.4960
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Manufacturing date

Other properties (13, all answered No)