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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture kit
Regulation Description Absorbable surgical gut suture.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeOVN
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 2 2
Failure to Cut 2 2
Product Quality Problem 2 2
Break 1 1
Mechanical Problem 1 1
Defective Component 1 1
Contamination 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
2 Medline Industries, LP II Jan-28-2026
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