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

Obstetrical Kit

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

OKV is the FDA product code for Obstetrical Kit, a class II device type, regulated under 21 CFR 884.4520. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold no 510(k) clearances under this code and 91 recalls.

Classification record

Product code
OKV
Device name
Obstetrical Kit
FDA definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Regulation
21 CFR 884.4520
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
91

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order