Bojrab 0385

by Medtronic Xomed Inc 2 variants

Bojrab 0385 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K823912 on 24 Jun 1983 and listed in FDA GUDID since 15 Jun 2015 (UDI-DI 00721902817427), active as of 8 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 8 Nov 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00721902817427 UDI-DI	Date15 Jun 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK823912	Date24 Jun 1983Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00721902817427
FDA 510(k) database 510(k) number K823912

Across registries

2 registries list this device

FDA 510(k) K823912 decided 24 Jun 1983 Active
FDA GUDID UDI-DI 00721902817427 listed 15 Jun 2015 Listed

Timeline

2 dated events

24 Jun 1983 Cleared FDA 510(k) K823912
15 Jun 2015 Listed FDA GUDID 00721902817427

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Bojrab
Generic name: Ossicular prosthesis, total
Model / reference: 0385

Primary DI / UDI-DI: 00721902817427
510(k) Number: K823912
FDA product code: ETA
GMDN term: Ossicular prosthesis, total

Device class: Class II
Regulation number: 874.3495
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10, all answered No)