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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hysterectomy kit
Regulation Description Obstetric-gynecologic specialized 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 CodeOJF
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 2 2
Break 1 1
Device Damaged Prior to Use 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Oct-26-2023
3 Cardinal Health 200, LLC II Feb-10-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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