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
1321 General & Plastic Surgery devices
Cleared
May 07, 2024
AEON Endoscopic Powered Stapler (Short/AEPH060)
GAG
Stapler, Surgical
138d
Cleared
May 07, 2024
Geneo X Elite
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
165d
Cleared
May 03, 2024
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
OAB
Low Energy Direct Current Thermal Ablation System
92d
Cleared
May 03, 2024
Cypris eXact Suture Placement Device
GEJ
Carrier, Ligature
101d
Cleared
May 03, 2024
VaporMAX LDD
GEX
Powered Laser Surgical Instrument
219d
Cleared
May 01, 2024
ORskin Blue
GEX
Powered Laser Surgical Instrument
229d
Cleared
Apr 30, 2024
Picosecond Nd:YAG Laser System
GEX
Powered Laser Surgical Instrument
105d
Cleared
Apr 29, 2024
Volnewmer™
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Apr 29, 2024
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
255d
Cleared
Apr 25, 2024
Kronos Electrocautery Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
226d
Cleared
Apr 25, 2024
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
KGN
Wound Dressing With Animal-derived Material(s)
226d
Cleared
Apr 25, 2024
ENDOFIX EXO
OCV
Endoscope Holder
259d
Cleared
Apr 25, 2024
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
NEW
Suture, Surgical, Absorbable, Polydioxanone
272d
Cleared
Apr 24, 2024
IPL Home Use Hair Removal Device (SJ15)
OHT
Light Based Over-the-counter Hair Removal
103d
Cleared
Apr 23, 2024
Dexcom G7 Continuous Glucose Monitoring System
QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
21d
Cleared
Apr 23, 2024
MeDioStar
GEX
Powered Laser Surgical Instrument
29d
Cleared
Apr 23, 2024
swiftPro™ System
NEY
System, Ablation, Microwave And Accessories
60d
Cleared
Apr 23, 2024
ReNew XR Handpiece, 25cm, with Reference Markings (3943M)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
116d
Cleared
Apr 23, 2024
BTL-499
GEI
Electrosurgical, Cutting & Coagulation & Accessories
140d
Cleared
Apr 23, 2024
mJOULE RF System and Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
574d
Cleared
Apr 19, 2024
Miro3D Fibers Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
30d
Cleared
Apr 19, 2024
FAQ™ 201, FAQ™ 202
OHS
Light Based Over The Counter Wrinkle Reduction
72d
Cleared
Apr 19, 2024
Hemoblock_S (Prescription)
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
268d
Cleared
Apr 19, 2024
ReyaGel (RG03 - MTP gel 3mL)
KGN
Wound Dressing With Animal-derived Material(s)
269d
Cleared
Apr 18, 2024
Prospera Spectruum Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
447d
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