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

Douche Apparatus, Vaginal, Therapeutic

21 CFR 884.5900 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HED is the FDA product code for Douche Apparatus, Vaginal, Therapeutic, a class I device type, regulated under 21 CFR 884.5900. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HED
Device name
Douche Apparatus, Vaginal, Therapeutic
Regulation
21 CFR 884.5900
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code HED

By decision year
12 clearances under product code HED with a decision year between 1978 and 2008, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HED by decision year
YearClearances
19781
19803
19831
19841
19861
19881
19901
20001
20031
20081

Applicants with the most clearances

Product code HED
Applicants holding the most 510(k) clearances under product code HED
ApplicantClearances
The Healthcare Group Laboratories, Inc.3
Abbott Research Group, Inc.1
Chatten Drug & Chemical Co.1
Corisen Group, Ltd.1
Geneva Laboratories, Inc.1
Goomi Ehwa, Inc.1
Mac Lee Medical Products1
Orion Life Systems, Inc.1
Pa Medical Corp.1
Snow Willow Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order