510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921885Substantially Equivalent

E1070 & E1080 Series Reusable Lletz Electrodes

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921885 is the FDA 510(k) clearance record for E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES, a class II device, cleared for Valleylab, Inc. on under FDA product code HGZ (Heater, Perineal, Direct Contact). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K921885.

Clearance record

Decision date
Received
(703 days to decision)
Product code
HGZ Heater, Perineal, Direct Contact
Regulation
21 CFR 884.5390
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
510(k) summary
Summary
Third party review
No

Clearances, product code HGZ

Trailing 12 months

FDA records hold no clearances under product code HGZ in the trailing twelve months.

FDA records show no clearances under product code HGZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260