FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
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
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13580 General & Plastic Surgery devices
Cleared
May 28, 2020
Frozen N
GEH
Unit, Cryosurgical, Accessories
149d
Cleared
May 28, 2020
REVOLVE ENVI 600 Advanced Adipose System
MUU
System, Suction, Lipoplasty
160d
Cleared
May 27, 2020
Medical Diode Laser Hair Removal System
GEX
Powered Laser Surgical Instrument
86d
Cleared
May 27, 2020
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
GEI
Electrosurgical, Cutting & Coagulation & Accessories
114d
Cleared
May 27, 2020
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
OLR
Oral Wound Dressing
177d
Cleared
May 26, 2020
GentleMax Pro Plus
GEX
Powered Laser Surgical Instrument
29d
Cleared
May 26, 2020
NPseal
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
110d
Cleared
May 22, 2020
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps
GEI
Electrosurgical, Cutting & Coagulation & Accessories
317d
Cleared
May 21, 2020
Photodynamic Therapy (PDT) Equipment
GEX
Powered Laser Surgical Instrument
59d
Cleared
May 21, 2020
SPY Portable Handheld Imaging (SPY-PHI) System
OWN
Confocal Optical Imaging
59d
Cleared
May 21, 2020
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
FBN
Choledochoscope And Accessories, Flexible/rigid
84d
Cleared
May 21, 2020
V30 system, V20 system, V10 system, V-FC Handpiece
PBX
Massager, Vacuum, Radio Frequency Induced Heat
85d
Cleared
May 21, 2020
gi-4000 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
274d
Cleared
May 18, 2020
3D GraftRasp System
FMF
Syringe, Piston
87d
Cleared
May 18, 2020
V.A.C. DERMATAC Drape
OMP
Negative Pressure Wound Therapy Powered Suction Pump
90d
Cleared
May 15, 2020
IPL Treatment Systems
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
53d
Cleared
May 14, 2020
VFS1 Bipolar Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
112d
Cleared
May 14, 2020
PAL Single-Use Cannulas
QPB
System, Suction, Lipoplasty For Removal
231d
Cleared
May 14, 2020
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
FRO
Dressing, Wound, Drug
248d
Cleared
May 14, 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
FRO
Dressing, Wound, Drug
314d
Cleared
May 13, 2020
308nm Excimer System
FTC
Light, Ultraviolet, Dermatological
232d
Cleared
May 11, 2020
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
GEI
Electrosurgical, Cutting & Coagulation & Accessories
41d
Cleared
May 11, 2020
ArtiSential Laparoscopic Instrument-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
73d
Cleared
May 11, 2020
PuraDERM Gel
FRO
Dressing, Wound, Drug
188d
Cleared
May 09, 2020
Dermalux Tri-Wave MD
GEX
Powered Laser Surgical Instrument
58d
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