510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PPPClass I

Disposable Joint Aspiration/Injection Kit

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

PPP is the FDA product code for Disposable Joint Aspiration/Injection Kit, a class I device type, regulated under 21 CFR 878.4800. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PPP
Device name
Disposable Joint Aspiration/Injection Kit
FDA 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.
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code