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
1318 General & Plastic Surgery devices
Cleared
Jul 19, 2024
Senhance Surgical System
NAY
System, Surgical, Computer Controlled Instrument
226d
Cleared
Jul 18, 2024
SOLID CLIP™ Single Use Clip Applier
FZP
Clip, Implantable
787d
Cleared
Jul 18, 2024
Field Shield Wound Dressing
FRO
Dressing, Wound, Drug
1073d
Cleared
Jul 15, 2024
Endoscopic Applicator, 41 cm
GCJ
Laparoscope, General & Plastic Surgery
28d
Cleared
Jul 15, 2024
RFG-01
PBX
Massager, Vacuum, Radio Frequency Induced Heat
174d
Cleared
Jul 15, 2024
CM00622 LINC Skin Closure System (CM00622 LINC)
OMD
Cutaneous Tissue Adhesive With Mesh
266d
Cleared
Jul 15, 2024
CM005 Standard (CM005)
MPN
Tissue Adhesive For The Topical Approximation Of Skin
266d
Cleared
Jul 12, 2024
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
84d
Cleared
Jul 12, 2024
Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
242d
Cleared
Jul 12, 2024
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
339d
Cleared
Jul 11, 2024
Cytal® Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
27d
Cleared
Jul 11, 2024
MicroMatrix® UBM Particulate
KGN
Wound Dressing With Animal-derived Material(s)
28d
Cleared
Jul 11, 2024
Sterile single use tip cleaner (WK800-S10 , WK800-S20)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
87d
Cleared
Jul 10, 2024
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
NEU
Marker, Radiographic, Implantable
138d
Cleared
Jul 10, 2024
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
OHT
Light Based Over-the-counter Hair Removal
190d
Cleared
Jul 09, 2024
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
OHT
Light Based Over-the-counter Hair Removal
57d
Cleared
Jul 09, 2024
deepLive
NQQ
System, Imaging, Optical Coherence Tomography (oct)
126d
Cleared
Jul 09, 2024
OW100S
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
208d
Cleared
Jul 08, 2024
LED Light Therapy Device, ELIXIR MD™
GEX
Powered Laser Surgical Instrument
61d
Cleared
Jul 08, 2024
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
138d
Cleared
Jul 05, 2024
SiOxD® Wound Matrix
QSZ
Absorbable Synthetic Wound Dressing
25d
Cleared
Jul 05, 2024
AMT Suture Passer
GCJ
Laparoscope, General & Plastic Surgery
74d
Cleared
Jul 03, 2024
ECHELON 3000 45mm Compact Stapler (ECH45C)
GAG
Stapler, Surgical
27d
Cleared
Jul 03, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
29d
Cleared
Jul 03, 2024
Dermablate
GEX
Powered Laser Surgical Instrument
29d
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