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
1314 General & Plastic Surgery devices
Cleared
Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
KNW
Instrument, Biopsy
29d
Cleared
Oct 28, 2024
Sterile Lancets for Single Use
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
55d
Cleared
Oct 28, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
OHS
Light Based Over The Counter Wrinkle Reduction
136d
Cleared
Oct 28, 2024
ECHELON 4000 60mm Compact Stapler (EC3D60C)
GDW
Staple, Implantable
144d
Cleared
Oct 25, 2024
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
OHT
Light Based Over-the-counter Hair Removal
28d
Cleared
Oct 25, 2024
Freeze Point & Private Label Versions
GEH
Unit, Cryosurgical, Accessories
52d
Not Cleared
Oct 25, 2024
Dexter L6 System
SDD
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
315d
Cleared
Oct 24, 2024
MagDI System (MAG-01, DS-01)
SAH
Magnetic Compression Anastomosis System
99d
Cleared
Oct 24, 2024
Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
GEX
Powered Laser Surgical Instrument
240d
Cleared
Oct 23, 2024
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
GCJ
Laparoscope, General & Plastic Surgery
61d
Cleared
Oct 23, 2024
Fractional CO2 Laser Therapy System (EXFU CO2)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Oct 22, 2024
PuraStat
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
83d
Cleared
Oct 22, 2024
KARL STORZ Holders
OCV
Endoscope Holder
244d
Cleared
Oct 21, 2024
PhotonBlade 3
GEI
Electrosurgical, Cutting & Coagulation & Accessories
81d
Cleared
Oct 21, 2024
Anovo Surgical System (Model 6Ne)
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
90d
Cleared
Oct 21, 2024
Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
FRO
Dressing, Wound, Drug
773d
Cleared
Oct 18, 2024
IceSeed 1.5 CX Straight Needle (H7493968333170)
GEH
Unit, Cryosurgical, Accessories
7d
Cleared
Oct 18, 2024
Corplex P/ Theracor P/ Allacor P
KGN
Wound Dressing With Animal-derived Material(s)
29d
Cleared
Oct 18, 2024
FREDDO
GEX
Powered Laser Surgical Instrument
88d
Cleared
Oct 18, 2024
Pixie Skin Tag
ORE
266d
Cleared
Oct 18, 2024
ABCcolla® Collagen ADM Scaffold
KGN
Wound Dressing With Animal-derived Material(s)
382d
Cleared
Oct 18, 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
GAP
Suture, Nonabsorbable, Silk
753d
Cleared
Oct 17, 2024
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
OHT
Light Based Over-the-counter Hair Removal
83d
Cleared
Oct 17, 2024
Microlyte Ag/Lidocaine
FRO
Dressing, Wound, Drug
1212d
Cleared
Oct 15, 2024
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
ILY
Lamp, Infrared, Therapeutic Heating
468d
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