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Sterilink™ 110V

by Plasmapp Co., Ltd. 3 variants

Sterilink™ 110V is a Class II device made by Plasmapp Co., Ltd., cleared under FDA 510(k) K231169 on 25 May 2023 (1 earlier submission) and listed in FDA GUDID since 13 Jul 2023 (UDI-DI 08800066500306), active as of 23 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 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800066500306 UDI-DI Date13 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK231169 Date25 May 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231169 decided 25 May 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800066500306 listed 13 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223015
  2. Cleared FDA 510(k) K231169
  3. Listed FDA GUDID 08800066500306

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sterilink™
Generic name
Plasma sterilizer
Model / reference
110V
Primary DI / UDI-DI
08800066500306
510(k) Number
FDA product code
MLR
GMDN term
Plasma sterilizer
Device class
Class II
Regulation number
880.6860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Plasma sterilizer

Other devices from Plasmapp Co., Ltd.

  • Sterlink™ BT96

    Class II

  • STERLINK™ Mini-bio

    Class II

  • Sterilink™ 110V

    Class II

  • Sterlink™ CD42

    Class II

See all devices from Plasmapp Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)