FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.
This panel covers a broad range of surgical equipment:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 136d |
| All-time average (cleared) | 115d |
| Not Substantially Equivalent (denied) | 423d |
Recent General & Plastic Surgery submissions have taken longer than the historical average - 136 days in the last 2 years vs 115 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 423 days before receiving a Not Substantially Equivalent determination.
This page lists all 18256 medical devices in the General & Plastic Surgery specialty that have been submitted to the FDA through the 510(k) premarket notification process. Surgical lasers, electrosurgical units, laparoscopic tools and wound care devices.
This page lists 18256 medical devices in the General & Plastic Surgery specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 18211 were cleared as substantially equivalent to a predicate device. Average FDA review time: 115 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.
Search all General & Plastic Surgery 510(k) devices