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
18146
Total
18103
Cleared
114d
Avg days
1976
Since
1296 General & Plastic Surgery devices
Cleared
Aug 19, 2025
Venclose digiRF Generator (VCRFG1)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
25d
Cleared
Aug 19, 2025
Remanufactured EndoWrist Tenaculum Forceps (420207)
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
176d
Cleared
Aug 19, 2025
Remanufactured EndoWrist Cadiere Forceps (420049)
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
188d
Cleared
Aug 19, 2025
Remanufactured EndoWrist Long Tip Forceps (420048)
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
189d
Cleared
Aug 19, 2025
Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
260d
Cleared
Aug 15, 2025
FEATHER 01 02 03 04 (Model:01)
OHS
Light Based Over The Counter Wrinkle Reduction
58d
Cleared
Aug 15, 2025
Helios Dermal Scaffold
KGN
Wound Dressing With Animal-derived Material(s)
184d
Cleared
Aug 14, 2025
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
OHT
Light Based Over-the-counter Hair Removal
120d
Cleared
Aug 14, 2025
TRUDERMAL Pro (ZLD-390)
OHS
Light Based Over The Counter Wrinkle Reduction
134d
Cleared
Aug 14, 2025
WinForth (LM-E470KA)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
140d
Cleared
Aug 14, 2025
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm)
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
142d
Cleared
Aug 13, 2025
HS Fiber
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
30d
Cleared
Aug 13, 2025
DOLORCLAST Focused Shock Waves
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
301d
Cleared
Aug 12, 2025
HOTWIRE™ System RF Generator and Footswitch (optional accessory)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
41d
Cleared
Aug 11, 2025
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Aug 11, 2025
XERF
GEI
Electrosurgical, Cutting & Coagulation & Accessories
103d
Cleared
Aug 11, 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
174d
Cleared
Aug 08, 2025
Diode laser device (BM091)
GEX
Powered Laser Surgical Instrument
57d
Cleared
Aug 08, 2025
swiftPro System (SWF-SPS)
NEY
System, Ablation, Microwave And Accessories
151d
Cleared
Aug 07, 2025
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
OHS
Light Based Over The Counter Wrinkle Reduction
69d
Cleared
Aug 06, 2025
Olo
GEX
Powered Laser Surgical Instrument
90d
Cleared
Aug 06, 2025
Viction Disposable Irrigation and suction System (VC-FLA0514
GCJ
Laparoscope, General & Plastic Surgery
201d
Cleared
Aug 06, 2025
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)
GCJ
Laparoscope, General & Plastic Surgery
201d
Cleared
Aug 04, 2025
CUTIVA™ Topical Skin Adhesive (RM1700)
MPN
Tissue Adhesive For The Topical Approximation Of Skin
129d
Cleared
Aug 01, 2025
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
OHT
Light Based Over-the-counter Hair Removal
59d
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