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Secret RF Main Unit MTR-C1

by CLASSYS Inc.

Secret RF Main Unit MTR-C1 is a Class II device made by CLASSYS Inc., cleared under FDA 510(k) K170325 on 13 Jun 2017 and listed in FDA GUDID since 30 Oct 2024 (UDI-DI 08800016903294), 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) K170325

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 Number08800016903294 UDI-DI Date30 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170325 Date13 Jun 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170325 decided 13 Jun 2017 Active
  • FDA GUDID UDI-DI 08800016903294 listed 30 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170325
  2. Listed FDA GUDID 08800016903294

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Secret RF Main Unit
Generic name
Intradermal radio-frequency ablation system
Model / reference
MTR-C1
Primary DI / UDI-DI
08800016903294
510(k) Number
FDA product code
GEI, OUH
GMDN term
Intradermal radio-frequency ablation system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intradermal radio-frequency ablation system

Cleared under the same submission (K170325)

and 2 more cleared under K170325

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)