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
13702 General & Plastic Surgery devices
Cleared
Dec 08, 2015
EVO platform
GEX
Powered Laser Surgical Instrument
140d
Not Cleared
Dec 08, 2015
Dignitana AB DigniCap System
PMC
Scalp Cooling System
277d
Cleared
Dec 07, 2015
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
PGZ
Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
84d
Cleared
Dec 07, 2015
Suntanning Lamps
LEJ
Booth, Sun Tan
102d
Cleared
Dec 01, 2015
Adler MicroMed Laser Surgery Fibers
GEX
Powered Laser Surgical Instrument
97d
Cleared
Nov 27, 2015
Stay Fresh Hydrocolloid dressing
FRO
Dressing, Wound, Drug
207d
Cleared
Nov 25, 2015
LARIAT RS Suture Delivery Device
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
30d
Cleared
Nov 25, 2015
Picasso Plus, Picasso Lite Plus
GEX
Powered Laser Surgical Instrument
51d
Cleared
Nov 25, 2015
DERMABOND PRINEO Skin Closure System
OMD
Cutaneous Tissue Adhesive With Mesh
85d
Cleared
Nov 24, 2015
OsteoCool V-3 RF Ablation System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
123d
Cleared
Nov 23, 2015
Ceramax Skin Barrier Cream
FRO
Dressing, Wound, Drug
122d
Cleared
Nov 19, 2015
SNaP Wound Care System
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
148d
Cleared
Nov 19, 2015
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
188d
Cleared
Nov 19, 2015
Medihoney Wound Gel
FRO
Dressing, Wound, Drug
219d
Cleared
Nov 19, 2015
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
FRO
Dressing, Wound, Drug
238d
Cleared
Nov 19, 2015
Aerin Medical Wand Model FG011
GEI
Electrosurgical, Cutting & Coagulation & Accessories
253d
Cleared
Nov 17, 2015
AUTOLAP SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Nov 17, 2015
TYRX Neuro Antibacterial Envelope
FTL
Mesh, Surgical, Polymeric
60d
Cleared
Nov 16, 2015
HairMD
OAP
Laser, Comb, Hair
118d
Cleared
Nov 12, 2015
PANTHER Cutter Stapler
GDW
Staple, Implantable
59d
Cleared
Nov 12, 2015
Valved Safety Centesis Catheter
GCB
Needle, Catheter
231d
Cleared
Nov 10, 2015
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
218d
Cleared
Nov 06, 2015
UTERMOHLEN CRYO PROFESSIONAL
GEH
Unit, Cryosurgical, Accessories
92d
Cleared
Nov 06, 2015
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
GCJ
Laparoscope, General & Plastic Surgery
144d
Cleared
Nov 06, 2015
CLIP PLUS Disposable Clip Applier,ML
FZP
Clip, Implantable
276d
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