FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
Nov 22, 2023
FITme Customized Silicone Implant
FWP
Prosthesis, Chin, Internal
89d
Cleared
Nov 22, 2023
Medifun Lancing Device, Model No. LD-E1
QRL
Multiple Use Blood Lancet For Single Patient Use Only
155d
Cleared
Nov 21, 2023
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
OWN
Confocal Optical Imaging
53d
Cleared
Nov 21, 2023
Biophotas Celluma CONTOUR
OLI
Fat Reducing Low Level Laser
61d
Cleared
Nov 20, 2023
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
52d
Cleared
Nov 20, 2023
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
52d
Cleared
Nov 20, 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
OHT
Light Based Over-the-counter Hair Removal
87d
Cleared
Nov 17, 2023
Celox Rapid X-Ray Gauze
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
260d
Cleared
Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
FRO
Dressing, Wound, Drug
297d
Cleared
Nov 16, 2023
NEUWAVE™ Microwave Ablation System and Accessories
NEY
System, Ablation, Microwave And Accessories
155d
Cleared
Nov 15, 2023
CoolSeal Trinity
GEI
Electrosurgical, Cutting & Coagulation & Accessories
219d
Cleared
Nov 14, 2023
IPL Cooling Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
61d
Cleared
Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
OLP
Over-the-counter Powered Light Based Laser For Acne
75d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
87d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
88d
Cleared
Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
NEY
System, Ablation, Microwave And Accessories
108d
Cleared
Nov 13, 2023
Microwave Ablation System (BD-GT)
NEY
System, Ablation, Microwave And Accessories
108d
Cleared
Nov 13, 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
KGN
Wound Dressing With Animal-derived Material(s)
136d
Cleared
Nov 10, 2023
Skin and Wound Cleanser
FRO
Dressing, Wound, Drug
163d
Cleared
Nov 09, 2023
TissueStat
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
190d
Cleared
Nov 09, 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
PBY
Temporary Tissue Marker
336d
Cleared
Nov 08, 2023
da Vinci SP Surgical System
NAY
System, Surgical, Computer Controlled Instrument
141d
Cleared
Nov 07, 2023
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
GCJ
Laparoscope, General & Plastic Surgery
53d
Cleared
Nov 06, 2023
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
52d
Cleared
Nov 03, 2023
Easycess Aspiration Pump
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
23d
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