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
1322 General & Plastic Surgery devices
Cleared
Feb 01, 2024
Resonic Rapid Acoustic Pulse Device
GEX
Powered Laser Surgical Instrument
64d
Cleared
Jan 31, 2024
Microwave Ablation Device (Exceed S10U)
NEY
System, Ablation, Microwave And Accessories
126d
Cleared
Jan 30, 2024
VIVA combo RF System (VIVA combo RF System)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
32d
Cleared
Jan 30, 2024
DermRays Revive
GEX
Powered Laser Surgical Instrument
215d
Cleared
Jan 27, 2024
Epilaser Pro
GEX
Powered Laser Surgical Instrument
121d
Cleared
Jan 25, 2024
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
106d
Cleared
Jan 25, 2024
Facet Aurora Reusable Lancet Base
QRL
Multiple Use Blood Lancet For Single Patient Use Only
128d
Cleared
Jan 23, 2024
SchurSign Tissue Marker
NEU
Marker, Radiographic, Implantable
302d
Cleared
Jan 22, 2024
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
OHT
Light Based Over-the-counter Hair Removal
45d
Cleared
Jan 22, 2024
NailLift
MQZ
Prosthesis, Nail
300d
Cleared
Jan 18, 2024
Arthrex Synergy Vision Endoscopic Imaging System
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Jan 18, 2024
FlashHeal 2 (FlashHeal 2.0)
GEX
Powered Laser Surgical Instrument
114d
Cleared
Jan 18, 2024
Progrip™ Self-Gripping Polypropylene Mesh
FTL
Mesh, Surgical, Polymeric
163d
Cleared
Jan 18, 2024
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
GEI
Electrosurgical, Cutting & Coagulation & Accessories
248d
Cleared
Jan 17, 2024
M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
KNW
Instrument, Biopsy
114d
Cleared
Jan 16, 2024
Disposable safety lancet (Impress)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
48d
Cleared
Jan 16, 2024
Non absorbable Surgical Silk Suture
GAP
Suture, Nonabsorbable, Silk
162d
Cleared
Jan 16, 2024
Uni-port
OTJ
Laparoscopic Single Port Access Device
189d
Cleared
Jan 12, 2024
Cypris eXact Suturing System
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
105d
Cleared
Jan 12, 2024
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
OHS
Light Based Over The Counter Wrinkle Reduction
107d
Cleared
Jan 12, 2024
Hem-o-lok® Ligating Clips
FZP
Clip, Implantable
113d
Cleared
Jan 12, 2024
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape))
NEU
Marker, Radiographic, Implantable
137d
Cleared
Jan 12, 2024
MD Mattress Suture Placement Device
GCJ
Laparoscope, General & Plastic Surgery
484d
Not Cleared
Jan 12, 2024
DermaSensor
QZS
Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
344d
Cleared
Jan 11, 2024
IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)
OHT
Light Based Over-the-counter Hair Removal
57d
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