KaWe 61-910-100

KaWe 61-910-100 is an ear speculum (FDA Class I; FDA product code FXG, Specula Accessories) made by BV Medical, listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00845821020871), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

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	Number00845821020871 UDI-DI	Date24 Sep 2018Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00845821020871

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: KaWe
Generic name: Ear speculum, single-use
Model / reference: 61-910-100

Primary DI / UDI-DI: 00845821020871
FDA product code: FXG
GMDN term: Ear speculum, single-use

Device class: Class I
Regulation number: 878.1800
GUDID distribution status: In Commercial Distribution

Other devices from Medical, Inc.

See all devices from Medical, Inc. →

Properties

Single use
Premarket exempt

Other properties (13, all answered No)