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

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

21 CFR 880.5240 / General Hospital
FDA source (opens on fda.gov)

PYO is the FDA product code for Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use, a class I device type, regulated under 21 CFR 880.5240. FDA's definition for this code reads: "A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PYO
Device name
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
FDA definition
A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PYO

By decision year
1 clearance under product code PYO with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PYO by decision year
YearClearances
20171

Applicants with the most clearances

Product code PYO
Applicants holding the most 510(k) clearances under product code PYO
ApplicantClearances
Zipline Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order