510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881216Substantially Equivalent

Gent-L-Kare Vaginal Irrigation Set

Geneva Laboratories, Inc., Elkhorn WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881216 is the FDA 510(k) clearance record for GENT-L-KARE VAGINAL IRRIGATION SET, a class I device, cleared for Geneva Laboratories, Inc. on under FDA product code HED (Douche Apparatus, Vaginal, Therapeutic). FDA records list 13 510(k) clearances for Geneva Laboratories, Inc., from to . As of , FDA records show no recalls naming K881216.

Clearance record

Decision date
Received
(77 days to decision)
Product code
HED Douche Apparatus, Vaginal, Therapeutic
Regulation
21 CFR 884.5900
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Geneva Laboratories, Inc. P.O. Box 444, Elkhorn WI
Third party review
No

Clearances, product code HED

Trailing 12 months

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

FDA records show no clearances under product code HED in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HED, 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