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

Drape, Surgical, Exempt

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

PUI is the FDA product code for Drape, Surgical, Exempt, a class II device type, regulated under 21 CFR 878.4370. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 41 recalls.

Classification record

Product code
PUI
Device name
Drape, Surgical, Exempt
FDA 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.
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
41

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 349 companies shown, in name order