PBY · Class II · 21 CFR 878.4300

FDA Product Code PBY: Temporary Tissue Marker

To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue.

Leading manufacturers include Sirius Medical Systems B.V..

7
Total
7
Cleared
191d
Avg days
2013
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Temporary Tissue Marker Devices (Product Code PBY)

7 devices
1–7 of 7
Cleared Nov 09, 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K223682
Sirius Medical Systems B.V.
General & Plastic Surgery · 336d
Cleared Oct 19, 2022
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K222643
Sirius Medical Systems B.V.
General & Plastic Surgery · 48d
Cleared Feb 24, 2021
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K200734
Sirius Medical Systems B.V.
General & Plastic Surgery · 341d

About Product Code PBY - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code PBY since 2013, with 7 receiving FDA clearance (average review time: 191 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.