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SureGuide 4034

by Clinicon Corp.

SureGuide 4034 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) K992472 on 8 Sep 1999 and listed in FDA GUDID since 6 May 2021 (UDI-DI 00850013050154), 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) K992472

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 Number00850013050154 UDI-DI Date6 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK992472 Date8 Sep 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K992472 decided 8 Sep 1999 Active
  • FDA GUDID UDI-DI 00850013050154 listed 6 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K992472
  2. Listed FDA GUDID 00850013050154

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureGuide
Generic name
General/multiple surgical laser system beam guide, single-use
Model / reference
4034
Primary DI / UDI-DI
00850013050154
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
Sterilisation method
Ethylene Oxide

Related devices

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

Cleared under the same submission (K992472)

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

  • SureProbe 4159

    Class II

  • SureScan 3566

    Class II

  • SureTip 3728

    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)