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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device obstetrical kit
Regulation Description Obstetric-gynecologic general manual instrument.
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
Product CodeOKV
Regulation Number 884.4520
Device Class 2

MDR Year MDR Reports MDR Events
2017 3 3
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 3 3
Entrapment of Device 2 2
Moisture Damage 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Packaging Compromised 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 Avid Medical, Inc. II Apr-19-2017
3 Customed, Inc II Apr-14-2016
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