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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cesarean section tray
Regulation Description Gynecologic laparoscope and accessories.
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 CodeOHM
Regulation Number 884.1720
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 8 8
2018 2 2
2019 10 10
2020 8 8
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 6 6
Break 5 5
Component Missing 4 4
Component Falling 3 3
Fire 2 2
Material Split, Cut or Torn 2 2
Fluid Leak 1 1
Delivered as Unsterile Product 1 1
Decrease in Suction 1 1
Detachment Of Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Cut 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Information 3 3
Foreign Body In Patient 3 3
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Customed, Inc II Apr-14-2016
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