Skin Prep Tray
The Skin Prep Tray is a convenience kit providing the components needed to prepare a patient's skin prior to surgery or an invasive procedure, typically including antiseptic solutions and applicators to reduce the risk of surgical site infection. Classified as FDA Class 1 under regulation 21 CFR 878.4800 within the General, Plastic Surgery medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are met. The product code is OJU. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- OJU
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K781797 | PREP TRAY, PREOPERATIVE SKIN | Nov 08, 1978 | Substantially Equivalent | Pharmaseal Div., Baxter Healthcare Corp. |
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.