Disposable Joint Aspiration/Injection Kit
The Disposable Joint Aspiration/Injection Kit is a convenience kit containing single-use supplies for aspirating fluid from or injecting medication into a joint, used in General and Plastic Surgery settings. It is classified as FDA Class 1 under 21 CFR 878.4800, subject to general controls only. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PPP; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPP
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- 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 http://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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.