510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841909Substantially Equivalent

Vaginal Speculum - Disposable

Galenica Enterprises, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841909 is the FDA 510(k) clearance record for VAGINAL SPECULUM - DISPOSABLE, a class II device, cleared for Galenica Enterprises, Inc. on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list 5 510(k) clearances for Galenica Enterprises, Inc., from to . As of , FDA records show one recall naming K841909.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Galenica Enterprises, Inc. 4221 Richmond Rd., NW, Walker MI
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