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
1322 General & Plastic Surgery devices
Cleared
Feb 27, 2024
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
81d
Cleared
Feb 26, 2024
Dexcom G7 Continuous Glucose Monitoring System
QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
59d
Cleared
Feb 23, 2024
Exceed Unlimited
QAI
Powered Microneedle Device
95d
Not Cleared
Feb 23, 2024
MIRA Surgical System
SAB
Table Mounted Miniaturized Electromechanical Surgical System
318d
Cleared
Feb 22, 2024
Oligio X
GEI
Electrosurgical, Cutting & Coagulation & Accessories
20d
Cleared
Feb 22, 2024
1688 4K Camera System with Advanced Imaging Modality
GCJ
Laparoscope, General & Plastic Surgery
30d
Cleared
Feb 22, 2024
Ulthera System (UC-1 Control Unit PRIME)
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
66d
Cleared
Feb 22, 2024
Quiver Aspiration Pump
BTA
Pump, Portable, Aspiration (manual Or Powered)
162d
Cleared
Feb 22, 2024
MultiPulse HoPLUS
GEX
Powered Laser Surgical Instrument
241d
Cleared
Feb 22, 2024
NanoDrop Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
428d
Cleared
Feb 20, 2024
Mjolnir Pro. (Multi–electrode plasma)
QVJ
Low Power Electrosurgical Devices For Skin Lesion Destruction
88d
Cleared
Feb 20, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
118d
Cleared
Feb 20, 2024
Diode Laser Therapy System
GEX
Powered Laser Surgical Instrument
237d
Cleared
Feb 16, 2024
Disposable Grounding Pad
GEI
Electrosurgical, Cutting & Coagulation & Accessories
226d
Cleared
Feb 14, 2024
Azure
GEX
Powered Laser Surgical Instrument
265d
Cleared
Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
90d
Cleared
Feb 12, 2024
SCOUT MD Surgical Guidance System
NEU
Marker, Radiographic, Implantable
266d
Cleared
Feb 09, 2024
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
GEI
Electrosurgical, Cutting & Coagulation & Accessories
212d
Cleared
Feb 08, 2024
Alma Harmony
GEX
Powered Laser Surgical Instrument
139d
Cleared
Feb 07, 2024
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
OAP
Laser, Comb, Hair
29d
Cleared
Feb 06, 2024
Cryojet Plus (SHE-ACP001-1)
GEX
Powered Laser Surgical Instrument
119d
Cleared
Feb 05, 2024
PREVENT Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
181d
Cleared
Feb 02, 2024
Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
GEX
Powered Laser Surgical Instrument
70d
Cleared
Feb 02, 2024
PiXel8-Reveal
GEX
Powered Laser Surgical Instrument
128d
Cleared
Feb 02, 2024
Corplex P / Theracor P / Allacor P
KGN
Wound Dressing With Animal-derived Material(s)
270d
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