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
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13875 General & Plastic Surgery devices
Cleared
Dec 27, 2006
CANDELA 3630 LASER SYSTEM
GEX
Powered Laser Surgical Instrument
82d
Cleared
Dec 22, 2006
HORUS LASER KERATOME
GEX
Powered Laser Surgical Instrument
136d
Cleared
Dec 22, 2006
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM
NTB
System, Ablation, Ultrasound And Accessories
315d
Cleared
Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
GEX
Powered Laser Surgical Instrument
75d
Cleared
Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES
GEX
Powered Laser Surgical Instrument
75d
Cleared
Dec 20, 2006
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
FRO
Dressing, Wound, Drug
232d
Cleared
Dec 19, 2006
U-CLIP DEVICE
FZP
Clip, Implantable
90d
Cleared
Dec 15, 2006
LASER-D68
GEX
Powered Laser Surgical Instrument
189d
Cleared
Dec 13, 2006
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
OMP
Negative Pressure Wound Therapy Powered Suction Pump
30d
Cleared
Dec 11, 2006
MUGARD MUCOADHESIVE ORAL WOUND RINSE
OLR
Oral Wound Dressing
84d
Cleared
Dec 11, 2006
BAND-AID(R) BRAND LIQUID BANDAGE
KMF
Bandage, Liquid
101d
Cleared
Dec 11, 2006
PROCEED VENTRAL PATCH
FTL
Mesh, Surgical, Polymeric
192d
Cleared
Dec 07, 2006
ABC HAIR REMOVAL SYSTEM
OHT
Light Based Over-the-counter Hair Removal
254d
Cleared
Dec 06, 2006
VERITAS COLLAGEN MATRIX
FTM
Mesh, Surgical
70d
Cleared
Dec 06, 2006
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
GEX
Powered Laser Surgical Instrument
196d
Cleared
Dec 06, 2006
G-PROX ENDOSCOPIC GRASPER
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
212d
Cleared
Dec 05, 2006
TRUEHD (1080P) DIGITAL CAMERA SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
20d
Cleared
Dec 04, 2006
TUFFLEX POLYESTER SUTURE
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
45d
Cleared
Dec 01, 2006
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
7d
Cleared
Dec 01, 2006
LOGIC LAPAROSCOPIC SCISSORS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
14d
Cleared
Dec 01, 2006
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
NAY
System, Surgical, Computer Controlled Instrument
38d
Cleared
Dec 01, 2006
REVLITE Q-SWITCHED ND:YAG LASER
GEX
Powered Laser Surgical Instrument
51d
Cleared
Dec 01, 2006
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
GEI
Electrosurgical, Cutting & Coagulation & Accessories
60d
Cleared
Dec 01, 2006
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
GEX
Powered Laser Surgical Instrument
80d
Cleared
Dec 01, 2006
NCONTACT COAGULATION SYSTEM KIT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
94d
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