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Generic 561215

by AMD Medicom Inc

Generic 561215 is a Class II device made by AMD Medicom Inc, cleared under FDA 510(k) K953829 on 9 Nov 1995 and listed in FDA GUDID since 7 Oct 2016 (UDI-DI D830561215), 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

510(k) K953829

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD830561215 UDI-DI Date7 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953829 Date9 Nov 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953829 decided 9 Nov 1995 Active
  • FDA GUDID UDI-DI D830561215 listed 7 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K953829
  2. Listed FDA GUDID D830561215

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Generic
Generic name
Sterilization packaging, single-use
Model / reference
561215
Primary DI / UDI-DI
D830561215
510(k) Number
FDA product code
KCT
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K953829)

and 8 more cleared under K953829

Other devices from AMD Medicom Inc

See all devices from AMD Medicom Inc →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)