FDA product code PBY: Temporary Tissue Marker
PBY is the FDA product code for temporary tissue marker. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under PBY, 2 in the last five years, from 4 different applicants. The average 510(k) review took 191 days (median 135).
Definition
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Classification
| Field | Value |
|---|---|
| Device name | Temporary Tissue Marker |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PBY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 75 |
| 2021 | 1 | 341 |
| 2022 | 1 | 48 |
| 2023 | 1 | 336 |
Top PBY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sirius Medical Systems B.V. | 3 | 2023-11-09 |
| Endomagnetics Ltd., | 2 | 2017-01-13 |
| Health Beacons, Inc. | 1 | 2017-04-28 |
| Cianna Medical | 1 | 2013-02-04 |
Most recent PBY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223682 | Sirius Medical Systems B.V. | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | 2023-11-09 | 336 |
| K222643 | Sirius Medical Systems B.V. | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | 2022-10-19 | 48 |
| K200734 | Sirius Medical Systems B.V. | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | 2021-02-24 | 341 |
| K163667 | Health Beacons, Inc. | 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) | 2017-04-28 | 122 |
| K163541 | Endomagnetics Ltd., | Magseed Magnetic Marker System | 2017-01-13 | 28 |
Recalls for PBY devices
openFDA lists no recalls for product code PBY.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4648 — Tissue marker, implantable, any type, each
Frequently asked questions
What is FDA product code PBY?
PBY is the FDA product code for temporary tissue marker. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is PBY?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBY?
Across 7 cleared submissions the average was 191 days from receipt to decision (median 135).
Which companies have the most PBY clearances?
Sirius Medical Systems B.V. (3); Endomagnetics Ltd., (2); Health Beacons, Inc. (1); Cianna Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PBY
- Run a recall and safety report across every PBY manufacturer
- Watch product code PBY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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