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AcuTron MOR-C1

by CLASSYS Inc.

AcuTron MOR-C1 is a Class II device made by CLASSYS Inc., cleared under FDA 510(k) K211000 on 9 Jun 2022 and listed in FDA GUDID since 30 Oct 2024 (UDI-DI 08800016904741), 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

510(k) K211000

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800016904741 UDI-DI Date30 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211000 Date9 Jun 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211000 decided 9 Jun 2022 Active
  • FDA GUDID UDI-DI 08800016904741 listed 30 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211000
  2. Listed FDA GUDID 08800016904741

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AcuTron
Generic name
Electrosurgical system
Model / reference
MOR-C1
Primary DI / UDI-DI
08800016904741
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical systemIntradermal radio-frequency ablation system

Cleared under the same submission (K211000)

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)