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510(k) K000768

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR by Wallach Surgical Devices, Inc. — Product Code EKZ

K000768 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR". The FDA issued a decision of Substantially Equivalent on April 11, 2000. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Wallach Surgical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2000
Date Received
March 9, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

Other clearances by Wallach Surgical Devices, Inc.

  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K020711 — WALLACH LOOP ELECTRODE (June 3, 2002)
  • 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)
  • 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 EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • K071632 — PERFECT TISSUE CONTOURING SYSTEM II (October 18, 2007)
  • K063468 — THE FUGO BLADE FOR DENTISTRY (April 18, 2007)
  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K020080 — BONART ART-E1 ELECTROSURGERY UNIT (February 19, 2002)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K982229 — BI-DENT (August 13, 1998)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)

FDA data resources