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

Cap, Cervical

21 CFR 884.5250 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDR is the FDA product code for Cap, Cervical, a class II device type, regulated under 21 CFR 884.5250. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HDR
Device name
Cap, Cervical
Regulation
21 CFR 884.5250
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
29
Ingested recalls
0

Clearances, product code HDR

By decision year
29 clearances under product code HDR with a decision year between 1981 and 2025, 1987 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code HDR by decision year
YearClearances
19811
19831
19862
19877
19882
19895
19906
19952
20001
20231
20251

Applicants with the most clearances

Product code HDR
Applicants holding the most 510(k) clearances under product code HDR
ApplicantClearances
Irvine Scientific LLC9
Cook Ob/Gyn3
Pharmacia, Inc.3
Axcan Scientific Corp.1
C.R. Bard Inc1
Cook Incorporated1
Epcom Medical Systems, Inc.1
I M, Inc.1
Imagyn Medical, Inc.1
JEDMED Instrument Company1

Companies listing this code with FDA

Companies whose registered establishments list this code