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SureProbe 4004

by Clinicon Corp.

SureProbe 4004 is a general/multiple surgical laser system beam guide (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Clinicon Corp., cleared under FDA 510(k) K014048 on 11 Feb 2002 and listed in FDA GUDID since 5 May 2021 (UDI-DI 00850013050062), 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) K014048

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 Number00850013050062 UDI-DI Date5 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK014048 Date11 Feb 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K014048 decided 11 Feb 2002 Active
  • FDA GUDID UDI-DI 00850013050062 listed 5 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K014048
  2. Listed FDA GUDID 00850013050062

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureProbe
Generic name
General/multiple surgical laser system beam guide, single-use
Model / reference
4004
Primary DI / UDI-DI
00850013050062
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical laser system beam guide, single-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: General/multiple surgical laser system beam guide, single-use

Cleared under the same submission (K014048)

and 7 more cleared under K014048

Similar devices in this category

Other devices filed under General/multiple surgical laser system beam guide, single-use.

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

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)