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Symmetry Olsen 30-2001

by Aspen Surgical Products, Inc.

Symmetry Olsen 30-2001 is a Class II device made by Aspen Surgical Products, Inc., cleared under FDA 510(k) K973234 on 27 Oct 1997 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00841785106347), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K973234

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841785106347 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973234 Date27 Oct 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973234 decided 27 Oct 1997 Active
  • FDA GUDID UDI-DI 00841785106347 listed 12 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0140-2010 FDA Unclassified (pre-2012) initiated 24 Sep 2009

    THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS

    • Terminated Z-0182-2007 FDA Unclassified (pre-2012) initiated 29 Aug 2006 on shared 510(k) K973234

    Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K973234
  2. Recall initiated FDA recalls Z-0182-2007
  3. Recall initiated FDA recalls Z-0140-2010
  4. Listed FDA GUDID 00841785106347

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Symmetry Olsen
Generic name
Open-surgery electrosurgical electrode, monopolar, single-use
Model / Ref / Catalog
30-2001
Primary DI / UDI-DI
00841785106347
510(k) Number
FDA product code
GEI
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 (K973234)

and 8 more cleared under K973234

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)