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
18327
Total
18282
Cleared
139d
Avg (2y)
1976
Since
14189 General & Plastic Surgery devices
Cleared
May 21, 1993
8-WATT PULSED DENTAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
94d
Cleared
May 21, 1993
2.5 WATT PULSED DENTAL LASER SYSTEM
GEX
Powered Laser Surgical Instrument
91d
Cleared
May 18, 1993
SALMAN SINUS BUTTON
KAM
Cannula, Sinus
336d
Cleared
May 17, 1993
ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M
GEI
Electrosurgical, Cutting & Coagulation & Accessories
399d
Cleared
May 17, 1993
OPTILITE FIBEROPTIC DELIVERY SYSTEMS
GEX
Powered Laser Surgical Instrument
301d
Cleared
May 17, 1993
# 9455 AND #9457 POOLE TIP SUCTION PROBE
GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
286d
Cleared
May 17, 1993
UNIVERSAL SURGICAL INSTRUMENT HOLDER
FWW
Table, Operating-room, Pneumatic
241d
Cleared
May 17, 1993
ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY
GEX
Powered Laser Surgical Instrument
236d
Cleared
May 17, 1993
VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E3200
GEI
Electrosurgical, Cutting & Coagulation & Accessories
145d
Cleared
May 17, 1993
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
FWF
Camera, Television, Endoscopic, Without Audio
131d
Cleared
May 12, 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
KGX
Tape And Bandage, Adhesive
315d
Cleared
May 12, 1993
3M TEGASORB THIN HYDROCOLLOID DRESSING
KMF
Bandage, Liquid
260d
Cleared
May 12, 1993
RIZZO NASAL IMPLANT
FZE
Prosthesis, Nose, Internal
197d
Cleared
May 12, 1993
PRE-TIED LOOP SUTURE CANNULA
GCJ
Laparoscope, General & Plastic Surgery
170d
Cleared
May 12, 1993
KENDALL UNIVERSAL EXTENSION SET
GBX
Catheter, Irrigation
98d
Cleared
May 07, 1993
MICROMANIPULATOR
GEX
Powered Laser Surgical Instrument
247d
Cleared
May 07, 1993
IRRIGATION/ASPIRATION TUBING SET
GAA
Needle, Aspiration And Injection, Disposable
182d
Cleared
May 05, 1993
NASAL CAVITY WOUND DRESSING
KMF
Bandage, Liquid
272d
Cleared
May 05, 1993
ACUFEX SUTURE RETRIEVER
GAE
Snare, Surgical
155d
Cleared
Apr 29, 1993
GUIDE WIRE FOR LAPOROSCOPIC USE
GCJ
Laparoscope, General & Plastic Surgery
140d
Cleared
Apr 29, 1993
AUTO SUTURE DILATING CANNULA
GCJ
Laparoscope, General & Plastic Surgery
44d
Cleared
Apr 27, 1993
ENDOPATH TISSUE EXTRACTION CANNULA
GCJ
Laparoscope, General & Plastic Surgery
63d
Cleared
Apr 26, 1993
PREP SHAVE KIT (NON-STERILE)
LRO
General Surgery Tray
214d
Cleared
Apr 23, 1993
LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
GCJ
Laparoscope, General & Plastic Surgery
305d
Cleared
Apr 23, 1993
SELECTOR
GCJ
Laparoscope, General & Plastic Surgery
192d
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