Suture Kit
The Suture Kit (product code OVN) is a convenience kit containing suture materials and associated components assembled for ease of use in surgical settings. Per FDA guidance from May 20, 1997, this type of convenience kit is under enforcement discretion and does not require a premarket notification (510(k)) to market, provided it meets all criteria in the applicable guidance document. As an FDA Class 2 device under regulation 878.4830, it falls within the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OVN
- Device Class
- FDA class 2
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.