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0363

by Medtronic Xomed Inc 2 variants

0363 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K885201 on 19 Apr 1989 and listed in FDA GUDID since 7 Nov 2021 (UDI-DI 00763000034290), 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

510(k) K885201

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000034290 UDI-DI Date7 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK885201 Date19 Apr 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K885201 decided 19 Apr 1989 Active
  • FDA GUDID UDI-DI 00763000034290 listed 7 Nov 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K885201
  2. Listed FDA GUDID 00763000034290

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ossicular prosthesis, total
Model / reference
0363
Primary DI / UDI-DI
00763000034290
510(k) Number
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
Size
Length — 7.0 Millimeter

Related devices

Category: Ossicular prosthesis, total

Cleared under the same submission (K885201)

and 8 more cleared under K885201

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)