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
1320 General & Plastic Surgery devices
Cleared
May 24, 2024
ALGS2 Ag Alginate Wound Dressing Rx
FRO
Dressing, Wound, Drug
240d
Cleared
May 24, 2024
Renasys Edge
OMP
Negative Pressure Wound Therapy Powered Suction Pump
329d
Cleared
May 23, 2024
3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
29d
Cleared
May 23, 2024
CWM-930S, FIXER DV9
GEI
Electrosurgical, Cutting & Coagulation & Accessories
239d
Cleared
May 23, 2024
3DMatrix Surgical Mesh
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
269d
Cleared
May 22, 2024
OviTex PRS
FTM
Mesh, Surgical
29d
Cleared
May 22, 2024
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
OHT
Light Based Over-the-counter Hair Removal
30d
Cleared
May 22, 2024
Bosley Booster 128 Laser Cap
OAP
Laser, Comb, Hair
97d
Cleared
May 22, 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
131d
Cleared
May 22, 2024
INUMI™ Flex Needle
OAB
Low Energy Direct Current Thermal Ablation System
166d
Cleared
May 22, 2024
Gladiator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
239d
Cleared
May 22, 2024
Bonvadis®
FRO
Dressing, Wound, Drug
265d
Cleared
May 21, 2024
Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
57d
Cleared
May 21, 2024
troCarWash™ System
OCX
Endoscopic Irrigation/suction System
216d
Cleared
May 20, 2024
Diode Laser Hair Removal System (SH-VD910)
GEX
Powered Laser Surgical Instrument
87d
Cleared
May 20, 2024
Multi-function Platform Systems (BL-M10)
GEX
Powered Laser Surgical Instrument
90d
Cleared
May 17, 2024
Intense Pulsed Light System (ST-690)
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
87d
Cleared
May 16, 2024
DEKA TORO
GEX
Powered Laser Surgical Instrument
58d
Cleared
May 16, 2024
Picosecond Nd:YAG Laser Systems (BL-C10)
GEX
Powered Laser Surgical Instrument
98d
Cleared
May 16, 2024
DEKA LOTUS
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
204d
Cleared
May 13, 2024
1060nm laser body slimming machine
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
66d
Cleared
May 10, 2024
HyperSuture Extension Line
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
140d
Cleared
May 08, 2024
Legend X Applicator VO
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
May 08, 2024
FLOW 90? Wand
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
May 08, 2024
UltraClear Laser System (N/A)
GEX
Powered Laser Surgical Instrument
161d
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