Home / 510(k) Clearances / K983840

510(k) K983840

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) by Wallach Surgical Devices, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1999
Date Received
October 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

Other clearances by Wallach Surgical Devices, Inc.

  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K020711 — WALLACH LOOP ELECTRODE (June 3, 2002)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (September 29, 1999)
  • K991669 — PMS 750 FINGERSWITCH (August 12, 1999)
  • K984306 — `THE INSEMINATOR' (PROPOSED) (March 1, 1999)
  • K983208 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (February 22, 1999)
  • K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM (June 11, 1997)
  • K963348 — WALLACH INTEGRATION UNIT (March 19, 1997)
  • K950630 — WALLACH DIGITAL IMAGING SYSTEM (November 22, 1995)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM (January 3, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K022593 — THOMAS MEDICAL ELECTRODES (November 1, 2002)
  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)