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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4099 General & Plastic Surgery devices
Cleared
Oct 19, 2018
AVELLE Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
268d
Cleared
Oct 18, 2018
Swift System
NEY
System, Ablation, Microwave And Accessories
90d
Cleared
Oct 18, 2018
Medax Biopsy Systems III
KNW
Instrument, Biopsy
105d
Cleared
Oct 17, 2018
Youlaser CO2
GEX
Powered Laser Surgical Instrument
22d
Cleared
Oct 16, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
NQQ
System, Imaging, Optical Coherence Tomography (oct)
56d
Cleared
Oct 12, 2018
Percuvance Percutaneous Surgical System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
93d
Cleared
Oct 11, 2018
Voyant Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
52d
Cleared
Oct 11, 2018
DemeTECH PTFE Nonabsorbable Surgical Suture
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
118d
Cleared
Oct 11, 2018
NeoMatriX Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
146d
Cleared
Oct 11, 2018
SCARLET SRF
GEI
Electrosurgical, Cutting & Coagulation & Accessories
191d
Cleared
Oct 11, 2018
Ergoline Prestige 1600 Hybrid Performance
LEJ
Booth, Sun Tan
224d
Cleared
Oct 10, 2018
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
99d
Cleared
Oct 09, 2018
Senhance Surgical System
NAY
System, Surgical, Computer Controlled Instrument
123d
Cleared
Oct 05, 2018
SHINY RPL System
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
85d
Cleared
Oct 02, 2018
Voyant System
HRX
Arthroscope
81d
Cleared
Oct 02, 2018
Deka Smartxide2 Trio
GEX
Powered Laser Surgical Instrument
82d
Cleared
Sep 28, 2018
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
98d
Cleared
Sep 27, 2018
Disposable Standard Clamp
GCJ
Laparoscope, General & Plastic Surgery
100d
Cleared
Sep 26, 2018
InMode RF System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
30d
Cleared
Sep 25, 2018
CPX 4 Breast Tissue Expander with Smooth Surface
LCJ
Tissue Expander And Accessories
28d
Cleared
Sep 25, 2018
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
NEU
Marker, Radiographic, Implantable
90d
Cleared
Sep 21, 2018
Cellulize
OLI
Fat Reducing Low Level Laser
226d
Cleared
Sep 21, 2018
SOLOASSIST II
NAY
System, Surgical, Computer Controlled Instrument
449d
Cleared
Sep 19, 2018
Scope Antifogging System
GCJ
Laparoscope, General & Plastic Surgery
48d
Cleared
Sep 19, 2018
Beurer IPL 8500 device/ IPL VelvetSkin Pro
OHT
Light Based Over-the-counter Hair Removal
79d
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