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
1305 General & Plastic Surgery devices
Cleared
Mar 12, 2025
DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
GCJ
Laparoscope, General & Plastic Surgery
27d
Cleared
Mar 12, 2025
PICOALEX
GEX
Powered Laser Surgical Instrument
79d
Cleared
Mar 11, 2025
8mm Monopolar Curved Scissors (470179)
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
189d
Cleared
Mar 10, 2025
Wound Treatment System (VHT-200)
KPJ
Chamber, Oxygen, Topical, Extremity
47d
Cleared
Mar 10, 2025
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
GAG
Stapler, Surgical
109d
Cleared
Mar 07, 2025
NOABLE LASER
GEX
Powered Laser Surgical Instrument
221d
Cleared
Mar 07, 2025
ATMOS C 051 Thorax (317.0200.0)
BTA
Pump, Portable, Aspiration (manual Or Powered)
259d
Cleared
Mar 06, 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
FRO
Dressing, Wound, Drug
161d
Cleared
Mar 06, 2025
XCELLARISPRO TWIST microneedling device
QAI
Powered Microneedle Device
258d
Cleared
Mar 05, 2025
NovoSorb® MTX
QSZ
Absorbable Synthetic Wound Dressing
225d
Cleared
Mar 03, 2025
Q Switched Nd:YAG Laser machine (QNHF-01)
GEX
Powered Laser Surgical Instrument
159d
Cleared
Mar 03, 2025
EnergyLounger (TY-01)
OHS
Light Based Over The Counter Wrinkle Reduction
243d
Cleared
Feb 28, 2025
da Vinci SP Advanced Access Port Kit (432701)
NAY
System, Surgical, Computer Controlled Instrument
100d
Cleared
Feb 28, 2025
MagDI System (MAG-02, DS-01)
SAH
Magnetic Compression Anastomosis System
122d
Cleared
Feb 27, 2025
XOD Diathermia Radiofrequency Device
PBX
Massager, Vacuum, Radio Frequency Induced Heat
218d
Cleared
Feb 26, 2025
DEKA LOTUS
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
26d
Cleared
Feb 26, 2025
Heel Incision Safety Lancet (SteriHeel 2)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
58d
Cleared
Feb 26, 2025
Disposable Blood Lancet (Soft Pro)
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
58d
Cleared
Feb 26, 2025
Vasoview Hemopro 3 Power Supply
GEI
Electrosurgical, Cutting & Coagulation & Accessories
68d
Cleared
Feb 25, 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
GDW
Staple, Implantable
132d
Cleared
Feb 24, 2025
Ulthera® System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
150d
Cleared
Feb 21, 2025
LYMA Laser PRO
OHS
Light Based Over The Counter Wrinkle Reduction
120d
Cleared
Feb 20, 2025
Medical diode laser systems (CHARISMA, REGAL)
GEX
Powered Laser Surgical Instrument
429d
Cleared
Feb 19, 2025
OPTOVISION Endoscopic Light Source Unit
OWN
Confocal Optical Imaging
91d
Cleared
Feb 19, 2025
Single Use CO2 Laser Fiber (HAF005001)
GEX
Powered Laser Surgical Instrument
91d
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