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PWUClass I

Clean-Up Kit

21 CFR 880.6890 / General Hospital
FDA source (opens on fda.gov)

PWU is the FDA product code for Clean-Up Kit, a class I device type, regulated under 21 CFR 880.6890. 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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PWU
Device name
Clean-Up 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 880.6890
Device class
Class I
Review panel
General Hospital
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