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
7622 General & Plastic Surgery devices
Cleared
Jul 19, 2019
Exceed Microneedling device
QAI
Powered Microneedle Device
318d
Cleared
Jul 18, 2019
MONTAGE-QS Settable, Resorbable Hemostatic Bone
MTJ
Wax, Bone
79d
Cleared
Jul 18, 2019
Silverlon Wound Contact, Burn Contact Dressings
FRO
Dressing, Wound, Drug
154d
Cleared
Jul 17, 2019
Pegasus System
HRX
Arthroscope
58d
Cleared
Jul 17, 2019
Powersculp laser lipolysis system
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
86d
Cleared
Jul 16, 2019
OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
GDW
Staple, Implantable
64d
Cleared
Jul 16, 2019
Biotex
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
456d
Cleared
Jul 12, 2019
Valleylab FT10 Electrosurgical Platform
GEI
Electrosurgical, Cutting & Coagulation & Accessories
25d
Cleared
Jul 12, 2019
StitchKit
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
58d
Cleared
Jul 12, 2019
Remington Medical, Inc. Automatic Cutting Needle (NAC)
KNW
Instrument, Biopsy
58d
Cleared
Jul 12, 2019
Stryker CrossFlow Integrated Arthroscopy Pump
HRX
Arthroscope
63d
Cleared
Jul 12, 2019
SureForm 45 Curved Tip, SureForm 45 Gray Reload
NAY
System, Surgical, Computer Controlled Instrument
87d
Cleared
Jul 12, 2019
PerioLase Nd:YAG Pulsed Dental Laser System
GEX
Powered Laser Surgical Instrument
263d
Cleared
Jul 11, 2019
Nuvis Battery Arthroscope
HRX
Arthroscope
24d
Cleared
Jul 11, 2019
Voyant System
HRX
Arthroscope
27d
Cleared
Jul 11, 2019
Senhance Surgical System
NAY
System, Surgical, Computer Controlled Instrument
37d
Cleared
Jul 11, 2019
AeroForm Tissue Expander, Smooth
PQN
Carbon Dioxide Gas Controlled Tissue Expander
72d
Cleared
Jul 10, 2019
MariGen Wound Extra
KGN
Wound Dressing With Animal-derived Material(s)
128d
Cleared
Jul 09, 2019
Gem FlowCoupler System
MVR
Device, Anastomotic, Microvascular
61d
Cleared
Jul 09, 2019
EpiLaze Multi-wavelength Laser
GEX
Powered Laser Surgical Instrument
69d
Cleared
Jul 09, 2019
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
KMK
Device, Intravascular Catheter Securement
449d
Cleared
Jul 08, 2019
Microwave Ablation System
NEY
System, Ablation, Microwave And Accessories
236d
Cleared
Jul 05, 2019
Arthrex NanoScope System
GCJ
Laparoscope, General & Plastic Surgery
114d
Cleared
Jul 02, 2019
PWD Platform Wound Dressing 3” x 5” Oblong
OMP
Negative Pressure Wound Therapy Powered Suction Pump
29d
Cleared
Jun 27, 2019
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
220d
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