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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7631 General & Plastic Surgery devices
Cleared
Jul 11, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
SEL
Securement Wound Dressing For Reduction Of Infection
15d
Cleared
Jul 07, 2017
Thunder, Thunder VT, Thunder HR
GEX
Powered Laser Surgical Instrument
28d
Cleared
Jun 29, 2017
Parietene DS Composite Mesh
FTL
Mesh, Surgical, Polymeric
225d
Cleared
Jun 13, 2017
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
NAY
System, Surgical, Computer Controlled Instrument
29d
Cleared
Jun 13, 2017
Sculpsure
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
60d
Cleared
Jun 13, 2017
da Vinci Xi Surgical System
NAY
System, Surgical, Computer Controlled Instrument
96d
Cleared
Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Jun 08, 2017
Novosyn Quick Absorbable Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
97d
Cleared
May 31, 2017
EndoWrist Stapler 45 System and Stapler 45 Reloads
NAY
System, Surgical, Computer Controlled Instrument
20d
Cleared
May 31, 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
GDW
Staple, Implantable
121d
Cleared
May 26, 2017
SutureTape
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
24d
Cleared
May 26, 2017
da Vinci X Surgical System
NAY
System, Surgical, Computer Controlled Instrument
24d
Cleared
May 25, 2017
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
28d
Cleared
May 24, 2017
Cook Holmium Laser Fiber
GEX
Powered Laser Surgical Instrument
190d
Cleared
May 23, 2017
Prontosan Wound Gel
FRO
Dressing, Wound, Drug
167d
Cleared
May 19, 2017
PK AIM
GEI
Electrosurgical, Cutting & Coagulation & Accessories
52d
Cleared
May 19, 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
FZP
Clip, Implantable
179d
Cleared
May 16, 2017
SIROLaser Advance+
GEX
Powered Laser Surgical Instrument
84d
Cleared
May 15, 2017
ULTRASHAPE POWER SYSTEM
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
98d
Cleared
May 15, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
SEL
Securement Wound Dressing For Reduction Of Infection
537d
Cleared
May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
FTL
Mesh, Surgical, Polymeric
143d
Cleared
May 05, 2017
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
NEY
System, Ablation, Microwave And Accessories
246d
Cleared
Apr 21, 2017
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Apr 21, 2017
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
NAY
System, Surgical, Computer Controlled Instrument
29d
Cleared
Apr 20, 2017
SlimShape System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
136d
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