510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800957Substantially Equivalent

Douche Unit-1500 Ml Disp. Container

The Healthcare Group Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800957 is the FDA 510(k) clearance record for DOUCHE UNIT-1500 ML DISP. CONTAINER, a class I device, cleared for The Healthcare Group Laboratories, Inc. on under FDA product code HED (Douche Apparatus, Vaginal, Therapeutic). FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from to . As of , FDA records show no recalls naming K800957.

Clearance record

Decision date
Received
(82 days to decision)
Product code
HED Douche Apparatus, Vaginal, Therapeutic
Regulation
21 CFR 884.5900
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
The Healthcare Group Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
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