Drape, Surgical, Exempt
The Drape, Surgical (Exempt) is a general/plastic surgery device used to cover and create a sterile field around the operative site during surgical procedures, protecting both the patient and the surgical team from contamination. Product code PUI is the Class II exempt counterpart of KKX, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 878.9. Under regulation 21 CFR 878.4370, it is a Class II device subject to general and special controls. It falls under the General Hospital review panel and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUI
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
FEI Numbers
This FDA classification entry is associated with 367 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 367 registration numbers. Click on an entry to view related FDA registrations.