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

Instrument, Manual, General Obstetric-Gynecologic

21 CFR 884.4520 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

KOH is the FDA product code for Instrument, Manual, General Obstetric-Gynecologic, a class I device type, regulated under 21 CFR 884.4520. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KOH
Device name
Instrument, Manual, General Obstetric-Gynecologic
Regulation
21 CFR 884.4520
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
15
Ingested recalls
2

Clearances, product code KOH

By decision year
15 clearances under product code KOH with a decision year between 1978 and 2000, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KOH by decision year
YearClearances
19782
19791
19801
19811
19831
19841
19871
19894
19942
20001

Applicants with the most clearances

Product code KOH
Applicants holding the most 510(k) clearances under product code KOH
ApplicantClearances
Zinnanti Surgical Instruments, Inc.3
Medikmark, Inc.2
American V. Mueller1
C. Intl.1
C.R. Bard Inc1
Imm Enterprises, Ltd.1
Karl Storz Endoscopy-America, Inc.1
M. Joel Gebhart, D.D.S.1
Ob/Gyn Concepts, Ltd.1
Reznik Instruments1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order