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510(k) K963653

WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM by Wallach Surgical Devices, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1997
Date Received
September 12, 1996
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)
  • K983840 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (May 20, 1999)
  • K984306 — `THE INSEMINATOR' (PROPOSED) (March 1, 1999)
  • K983208 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (February 22, 1999)
  • K963348 — WALLACH INTEGRATION UNIT (March 19, 1997)
  • K950630 — WALLACH DIGITAL IMAGING SYSTEM (November 22, 1995)

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  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
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  • 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)