FDA 510(k) General & Plastic Surgery Devices
About General & Plastic Surgery Devices
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:
- Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
- Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
- Laparoscopic instruments - trocars, graspers, staplers, clip appliers
- Wound care and closure - negative pressure therapy, staples, tissue adhesives
- Aesthetic devices - body contouring, skin resurfacing, fat reduction systems
FDA 510(k) Cleared General & Plastic Surgery Devices
This page lists all 18146 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.
- 18103 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 114 days.
- Records available from 1976 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 18146 medical devices in the General & Plastic Surgery specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 18103 were cleared as substantially equivalent to a predicate device. Average FDA review time: 114 days. Records from 1976 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to general & plastic surgery
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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