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Surescan

by Clinicon Corp. 2 variants

510(k) K964831

Surescan is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Clinicon Corp., cleared under FDA 510(k) K964831 on 8 Aug 1997, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964831 Date8 Aug 1997ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Devices cleared under K964831

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K964831
UDI-DISize and differences
SureScan 3566
Clinicon Corp.
356600850013050192 —On the market

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. →