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

Culdoscope (And Accessories)

21 CFR 884.1640 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HEW is the FDA product code for Culdoscope (And Accessories), a class II device type, regulated under 21 CFR 884.1640. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
HEW
Device name
Culdoscope (And Accessories)
Regulation
21 CFR 884.1640
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
No
Ingested clearances
18
Ingested recalls
4

Clearances, product code HEW

By decision year
18 clearances under product code HEW with a decision year between 1996 and 2025, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HEW by decision year
YearClearances
19962
19971
19981
20002
20041
20052
20111
20121
20152
20161
20181
20191
20201
20251

Applicants with the most clearances

Product code HEW
Applicants holding the most 510(k) clearances under product code HEW
ApplicantClearances
CooperSurgical, Inc.4
Applied Medical Resources Corp3
Karl Storz Endoscopy-America, Inc.3
Circon Corp.1
Gynetech Pty., Ltd.1
Insitu Systems1
J.Singh Instruments1
Lsi Solutions Inc.1
Richard Wolf Medical Instruments Corp.1
Soprane S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order