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

Diaphragm, Contraceptive (And Accessories)

21 CFR 884.5350 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDW is the FDA product code for Diaphragm, Contraceptive (And Accessories), a class II device type, regulated under 21 CFR 884.5350. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HDW
Device name
Diaphragm, Contraceptive (And Accessories)
Regulation
21 CFR 884.5350
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
3

Clearances, product code HDW

By decision year
4 clearances under product code HDW with a decision year between 1980 and 2014, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HDW by decision year
YearClearances
19801
20082
20141

Applicants with the most clearances

Product code HDW
Applicants holding the most 510(k) clearances under product code HDW
ApplicantClearances
CooperSurgical, Inc.1
G.D. Searle and Co.1
Johnson & Johnson Produtos Profissionais Ltda.1
Kessel Medintim GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code