510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K922154Substantially Equivalent

Insulated Speculum W/ Smoke Evacuator Option

Olsen Electrosurgical, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922154 is the FDA 510(k) clearance record for INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION, a class II device, cleared for Olsen Electrosurgical, Inc. on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list 11 510(k) clearances for Olsen Electrosurgical, Inc., from to . As of , FDA records show no recalls naming K922154.

Clearance record

Decision date
Received
(714 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Olsen Electrosurgical, Inc. 2100 Meridian Park Blvd., Concord CA
510(k) summary
Statement
Third party review
No

Clearances, product code HIB

Trailing 12 months
1 clearance under product code HIB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260