Home / 510(k) Clearances / K921885

510(k) K921885

E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES by Valleylab, Inc. — Product Code HGZ

K921885 is an FDA 510(k) premarket notification submitted by Valleylab, Inc. for the device "E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES". The FDA issued a decision of Substantially Equivalent on March 25, 1994. The device falls under product code HGZ (Heater, Perineal, Direct Contact), a Class II device regulated under 21 CFR 884.5390. Valleylab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1994
Date Received
April 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Perineal, Direct Contact
Device Class
Class II
Regulation Number
884.5390
Review Panel
OB
Submission Type

Other clearances by Valleylab, Inc.

  • K092879 — LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER (October 16, 2009)
  • K063195 — LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS L (November 29, 2006)
  • K053535 — VIVAWAVE MICROWAVE ABLATION SYSTEM (April 27, 2006)
  • K053290 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (March 15, 2006)
  • K052796 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (February 3, 2006)
  • K051644 — VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR (August 11, 2005)
  • K051627 — VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT (July 22, 2005)
  • K043273 — LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS (January 5, 2005)
  • K042216 — COOL-TIP RF ABLATION SYSTEM (November 12, 2004)
  • K041587 — LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # (September 28, 2004)

FDA data resources