510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781207Substantially Equivalent

Douche Kit, Something Personal

Chatten Drug & Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781207 is the FDA 510(k) clearance record for DOUCHE KIT, SOMETHING PERSONAL, a class I device, cleared for Chatten Drug & Chemical Co. on under FDA product code HED (Douche Apparatus, Vaginal, Therapeutic). FDA records list one 510(k) clearance for Chatten Drug & Chemical Co. As of , FDA records show no recalls naming K781207.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HED Douche Apparatus, Vaginal, Therapeutic
Regulation
21 CFR 884.5900
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Chatten Drug & Chemical Co. 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