510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PBYClass II

Temporary Tissue Marker

21 CFR 878.4300 / General, Plastic Surgery
FDA source (opens on fda.gov)

PBY is the FDA product code for Temporary Tissue Marker, a class II device type, regulated under 21 CFR 878.4300. FDA's definition for this code reads: "To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PBY
Device name
Temporary Tissue Marker
FDA definition
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code PBY

By decision year
7 clearances under product code PBY with a decision year between 2013 and 2023, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PBY by decision year
YearClearances
20131
20161
20172
20211
20221
20231

Applicants with the most clearances

Product code PBY
Applicants holding the most 510(k) clearances under product code PBY
ApplicantClearances
Sirius Medical Systems B.V.3
Endomagnetics Ltd2
Cianna Medical, Inc.1
Health Beacons, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code