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., Endomagnetics Ltd., and Cianna Medical.
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
Cleared
Nov 09, 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Sirius Medical Systems B.V.
General & Plastic Surgery
336d
Cleared
Oct 19, 2022
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Sirius Medical Systems B.V.
General & Plastic Surgery
48d
Cleared
Feb 24, 2021
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Sirius Medical Systems B.V.
General & Plastic Surgery
341d
Cleared
Apr 28, 2017
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
Health Beacons, Inc.
General & Plastic Surgery
122d
Cleared
Jan 13, 2017
Magseed Magnetic Marker System
Endomagnetics Ltd.,
General & Plastic Surgery
28d
Cleared
Mar 02, 2016
Sentimag System, Sentimark Magnetic Marker Systerm
Endomagnetics Ltd.,
General & Plastic Surgery
135d
Cleared
Feb 04, 2013
CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
Cianna Medical
General & Plastic Surgery
325d
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.