← FDA Medical Device Classifications
Temporary Tissue Marker
PBY · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4300
Classification
- FDA Product Code
PBY- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4300
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Market data
- Cleared 510(k) submissions
- 7
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown