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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
OMP
Negative Pressure Wound Therapy Powered Suction Pump
250d
Cleared
Jan 05, 2022
Urethral Warming Catheter Kit
GEH
Unit, Cryosurgical, Accessories
261d
Cleared
Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
Cleared
Jan 04, 2022
InnoClip Disposable Clip Applier, InnoClip Clip Applier
FZP
Clip, Implantable
460d
Cleared
Dec 30, 2021
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
GDW
Staple, Implantable
233d
Cleared
Dec 30, 2021
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
457d
Cleared
Dec 22, 2021
Diode Laser System GP900A8, Diode Laser System GP900Q8
GEX
Powered Laser Surgical Instrument
84d
Cleared
Dec 22, 2021
ID-500 iRestore Hair Growth System
OAP
Laser, Comb, Hair
89d
Cleared
Dec 22, 2021
Oren LED Perioral Light Therapy System
OHS
Light Based Over The Counter Wrinkle Reduction
92d
Cleared
Dec 22, 2021
Non Absorbable Surgical Nylon Suture
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
127d
Cleared
Dec 21, 2021
TheraFace LED
OHS
Light Based Over The Counter Wrinkle Reduction
162d
Cleared
Dec 21, 2021
reVive Light Therapy Essentials
OLP
Over-the-counter Powered Light Based Laser For Acne
265d
Cleared
Dec 20, 2021
Frax 1940 for Nordlys and Frax Pro
GEX
Powered Laser Surgical Instrument
133d
Cleared
Dec 20, 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
217d
Cleared
Dec 20, 2021
IPL Home Use Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
244d
Cleared
Dec 17, 2021
Single Use Electrosurgical Knife with Fluid Pump System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
242d
Cleared
Dec 17, 2021
PDO Max Suture with Dual Needle
NEW
Suture, Surgical, Absorbable, Polydioxanone
268d
Cleared
Dec 17, 2021
MED RF 4000
ONQ
Electrosurgical Coagulation For Aesthetic
339d
Cleared
Dec 16, 2021
IPL hair removal machine
OHT
Light Based Over-the-counter Hair Removal
87d
Cleared
Dec 16, 2021
Connected OR Hub with Device and Voice Control
GCJ
Laparoscope, General & Plastic Surgery
168d
Cleared
Dec 16, 2021
Theia NPWT Foam Wound Dressing Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
233d
Cleared
Dec 16, 2021
Profound Matrix
GEI
Electrosurgical, Cutting & Coagulation & Accessories
237d
Cleared
Dec 16, 2021
Voyant Fine Fusion Device (EB230)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
448d
Cleared
Dec 15, 2021
Cellusheet, Cellufil
KGN
Wound Dressing With Animal-derived Material(s)
82d
Cleared
Dec 15, 2021
reVive Light Therapy Essentials
OHS
Light Based Over The Counter Wrinkle Reduction
259d
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