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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4045 General & Plastic Surgery devices
Cleared
Oct 28, 2020
Ultimate Contour, Ultimate Contour Mini
PBX
Massager, Vacuum, Radio Frequency Induced Heat
147d
Cleared
Oct 28, 2020
NP1 Instrument, Creo Electrosurgical System
NEY
System, Ablation, Microwave And Accessories
300d
Cleared
Oct 23, 2020
SURGIPHOR Wound Irrigation System
FQH
Lavage, Jet
88d
Cleared
Oct 23, 2020
PocketDoc™ Micro Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
268d
Cleared
Oct 22, 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
GEX
Powered Laser Surgical Instrument
58d
Cleared
Oct 21, 2020
ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
GEI
Electrosurgical, Cutting & Coagulation & Accessories
105d
Cleared
Oct 21, 2020
InnovaMatrix
KGN
Wound Dressing With Animal-derived Material(s)
306d
Cleared
Oct 21, 2020
C4 Fiducial Marker
NEU
Marker, Radiographic, Implantable
387d
Cleared
Oct 20, 2020
WEGO-PDO Barbed Suture
NEW
Suture, Surgical, Absorbable, Polydioxanone
175d
Cleared
Oct 19, 2020
anti-bacterial bandage
FRO
Dressing, Wound, Drug
203d
Cleared
Oct 16, 2020
Medline Smoke Evacuation Pencil
GEI
Electrosurgical, Cutting & Coagulation & Accessories
171d
Cleared
Oct 15, 2020
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
GDW
Staple, Implantable
31d
Cleared
Oct 15, 2020
Opera Evo
GEX
Powered Laser Surgical Instrument
84d
Cleared
Oct 09, 2020
AEON Endoscopic Stapler
GDW
Staple, Implantable
93d
Cleared
Oct 08, 2020
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
GCJ
Laparoscope, General & Plastic Surgery
30d
Cleared
Oct 08, 2020
SilverStream Gel
FRO
Dressing, Wound, Drug
197d
Cleared
Oct 06, 2020
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
GEI
Electrosurgical, Cutting & Coagulation & Accessories
68d
Cleared
Oct 02, 2020
Arthrex SoftStitch
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
563d
Cleared
Sep 28, 2020
Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
145d
Cleared
Sep 28, 2020
da Vinci SP Surgical System
NAY
System, Surgical, Computer Controlled Instrument
367d
Cleared
Sep 25, 2020
Restrata®
QSZ
Absorbable Synthetic Wound Dressing
277d
Cleared
Sep 24, 2020
Dermal Cooling System
GEH
Unit, Cryosurgical, Accessories
136d
Cleared
Sep 18, 2020
Ran-Flex-B Bone Marrow Aspiration Needle
KNW
Instrument, Biopsy
37d
Cleared
Sep 18, 2020
Electrosurgical Generator and Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
135d
Cleared
Sep 10, 2020
HS Fiber
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
31d
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