DeviceClearance

Product code PBY— General, Plastic Surgery

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Classification name
Temporary Tissue Marker
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

FDA classification definition

“To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.”

— U.S. Food and Drug Administration, device classification record for product code PBY under 21 CFR 878.4300, via openFDA

Market context for product code PBY

FDA has cleared 7 devices under product code PBY between 2013 and 2023, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PBY

Recent clearances under product code PBY

Data sourced from openFDA. This site is unofficial and independent of the FDA.