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Sterimed PC0512

by Sterimed, Inc.

Sterimed PC0512 is a Class II device made by Sterimed, Inc., cleared under FDA 510(k) K853044 on 1 Nov 1985 and listed in FDA GUDID since 24 Jan 2017 (UDI-DI 00850341007974), 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) K853044

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 Number00850341007974 UDI-DI Date24 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK853044 Date1 Nov 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K853044 decided 1 Nov 1985 Active
  • FDA GUDID UDI-DI 00850341007974 listed 24 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K853044
  2. Listed FDA GUDID 00850341007974

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sterimed
Generic name
Cable/lead/sensor/probe cover, sterile
Model / reference
PC0512
Primary DI / UDI-DI
00850341007974
510(k) Number
FDA product code
IZI
GMDN term
Cable/lead/sensor/probe cover, sterile
Device class
Class II
Regulation number
892.1600
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cable/lead/sensor/probe cover, sterile

Cleared under the same submission (K853044)

and 8 more cleared under K853044

Similar devices

Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).

Other devices from Sterimed, Inc.

See all devices from Sterimed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (11, all answered No)