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Max-64C

by CLASSYS Inc.

Max-64C is a Class II device made by CLASSYS Inc., cleared under FDA 510(k) K241157 on 21 Nov 2024 and listed in FDA GUDID since 2 Jul 2025 (UDI-DI 08800016903447), active as of 1 Jun 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 1 Jun 2026

Documents

510(k) K241157

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800016903447 UDI-DI Date2 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241157 Date21 Nov 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241157 decided 21 Nov 2024 Active
  • FDA GUDID UDI-DI 08800016903447 listed 2 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241157
  2. Listed FDA GUDID 08800016903447

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Open-surgery electrosurgical electrode, monopolar, single-use
Model / reference
MAX-64C
Primary DI / UDI-DI
08800016903447
510(k) Number
FDA product code
OUH
GMDN term
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open-surgery electrosurgical electrode, monopolar, single-use

Cleared under the same submission (K241157)

and 8 more cleared under K241157

Similar devices in this category

Other devices filed under Open-surgery electrosurgical electrode, monopolar, single-use.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)