Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300) → PBY — Temporary Tissue Marker

# PBY · Temporary Tissue Marker

_General, Plastic Surgery · 21 CFR 878.4300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY

## Overview

- **Product Code:** PBY
- **Device Name:** Temporary Tissue Marker
- **Regulation:** [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K223682](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K223682.md) | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | Nov 9, 2023 | SESE |
| [K222643](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K222643.md) | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | Oct 19, 2022 | SESE |
| [K200734](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K200734.md) | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | Feb 24, 2021 | SESE |
| [K163667](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K163667.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K163541.md) | Magseed Magnetic Marker System | Endomagnetics Ltd., | Jan 13, 2017 | SESE |
| [K153044](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K153044.md) | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | Mar 2, 2016 | SESE |
| [K120804](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY/K120804.md) | 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
- Cianna Medical — 1 clearance
- Health Beacons, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBY)

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