Skip to content

SureBlade 2572

by Clinicon Corp.

SureBlade 2572 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Clinicon Corp., cleared under FDA 510(k) K983463 on 11 Dec 1998 and listed in FDA GUDID since 5 May 2021 (UDI-DI 00850013050130), 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) K983463

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 Number00850013050130 UDI-DI Date5 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983463 Date11 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983463 decided 11 Dec 1998 Active
  • FDA GUDID UDI-DI 00850013050130 listed 5 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983463
  2. Listed FDA GUDID 00850013050130

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureBlade
Generic name
General/multiple surgical diode/carbon dioxide laser system
Model / reference
2572
Primary DI / UDI-DI
00850013050130
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical diode/carbon dioxide laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: General/multiple surgical diode/carbon dioxide laser system

Cleared under the same submission (K983463)

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Clinicon Corp.

  • SureProbe 4002

    Class II

  • SureGuide 4034

    Class II

  • SureProbe 4159

    Class II

  • SureScan 3566

    Class II

See all devices from Clinicon Corp. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)