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
14008 General & Plastic Surgery devices
Cleared
Jul 31, 2001
SCALPFIX CLIP SYSTEM
HBO
Clip, Scalp
15d
Cleared
Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
LFL
Instrument, Ultrasonic Surgical
29d
Cleared
Jul 24, 2001
INTUITIVE SURGICAL ULTRASONIC SHEARS
NAY
System, Surgical, Computer Controlled Instrument
88d
Cleared
Jul 19, 2001
ENTEC EVAC PLASMA WAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
83d
Cleared
Jul 19, 2001
ENDOPOUCH RETRIEVER
GCJ
Laparoscope, General & Plastic Surgery
64d
Cleared
Jul 16, 2001
BIOPSY SITE MARKER
FZP
Clip, Implantable
70d
Cleared
Jul 13, 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
GCJ
Laparoscope, General & Plastic Surgery
80d
Cleared
Jul 13, 2001
MEDLINE GROUNDING PAD
JOS
Electrode, Electrosurgical
57d
Cleared
Jul 10, 2001
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
GCJ
Laparoscope, General & Plastic Surgery
13d
Cleared
Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jul 03, 2001
WATERLASE, MILLENNIUM
GEX
Powered Laser Surgical Instrument
89d
Cleared
Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
56d
Cleared
Jun 28, 2001
MODIFICATION TO KSEA ENDOTIP SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
56d
Cleared
Jun 22, 2001
AMS SLING FIXATION SYSTEM
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
80d
Cleared
Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
GEI
Electrosurgical, Cutting & Coagulation & Accessories
21d
Cleared
Jun 18, 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
GCJ
Laparoscope, General & Plastic Surgery
87d
Cleared
Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
GEX
Powered Laser Surgical Instrument
37d
Cleared
May 31, 2001
LAPAROSCOPIC HAND PORT
GCJ
Laparoscope, General & Plastic Surgery
167d
Cleared
May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
LFL
Instrument, Ultrasonic Surgical
66d
Cleared
May 30, 2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
NAY
System, Surgical, Computer Controlled Instrument
57d
Cleared
May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
MGQ
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
87d
Cleared
May 22, 2001
PALOMAR SLP 1000
GEX
Powered Laser Surgical Instrument
84d
Cleared
May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
GEX
Powered Laser Surgical Instrument
62d
Cleared
May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
OXD
Mesh, Surgical, Non-absorbable, Staple Line Reinforcement
54d
Cleared
May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
GEX
Powered Laser Surgical Instrument
71d
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