PBY · Temporary Tissue Marker
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | PBY |
|---|---|
| Device Name | Temporary Tissue Marker |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | Nov 9, 2023 | SESE |
| K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | Oct 19, 2022 | SESE |
| K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | Feb 24, 2021 | SESE |
| K163667 | 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. | Apr 28, 2017 | SESE |
| K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | Jan 13, 2017 | SESE |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | Mar 2, 2016 | SESE |
| K120804 | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM | Cianna Medical | Feb 4, 2013 | SESE |
Top Applicants
- Sirius Medical Systems B.V. — 3 clearances
- Endomagnetics Ltd., — 2 clearances
- Health Beacons, Inc. — 1 clearance
- Cianna Medical — 1 clearance
