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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7526 General & Plastic Surgery devices
Cleared
Nov 15, 2023
CoolSeal Trinity
GEI
Electrosurgical, Cutting & Coagulation & Accessories
219d
Cleared
Nov 14, 2023
IPL Cooling Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
61d
Cleared
Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
OLP
Over-the-counter Powered Light Based Laser For Acne
75d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
87d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
88d
Cleared
Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
NEY
System, Ablation, Microwave And Accessories
108d
Cleared
Nov 13, 2023
Microwave Ablation System (BD-GT)
NEY
System, Ablation, Microwave And Accessories
108d
Cleared
Nov 13, 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
KGN
Wound Dressing With Animal-derived Material(s)
136d
Cleared
Nov 10, 2023
Skin and Wound Cleanser
FRO
Dressing, Wound, Drug
163d
Cleared
Nov 09, 2023
TissueStat
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
190d
Cleared
Nov 09, 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
PBY
Temporary Tissue Marker
336d
Cleared
Nov 08, 2023
da Vinci SP Surgical System
NAY
System, Surgical, Computer Controlled Instrument
141d
Cleared
Nov 07, 2023
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
GCJ
Laparoscope, General & Plastic Surgery
53d
Cleared
Nov 06, 2023
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
52d
Cleared
Nov 03, 2023
Easycess Aspiration Pump
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
23d
Cleared
Nov 03, 2023
SCIZER (SC1-M410)
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
294d
Cleared
Nov 02, 2023
Nd:Yag Laser Therapy Systems
GEX
Powered Laser Surgical Instrument
73d
Cleared
Nov 01, 2023
Bard 3DMax Mesh
FTL
Mesh, Surgical, Polymeric
28d
Cleared
Nov 01, 2023
Inzii Ripstop Redeployable Retrieval System
GCJ
Laparoscope, General & Plastic Surgery
44d
Cleared
Oct 30, 2023
NuEra Tight RF Model OptiStream
PBX
Massager, Vacuum, Radio Frequency Induced Heat
227d
Cleared
Oct 27, 2023
EnCor Enspire™Breast Biopsy System (E4115, E4230)
KNW
Instrument, Biopsy
29d
Cleared
Oct 27, 2023
DEKA AGAIN PRO family
GEX
Powered Laser Surgical Instrument
31d
Cleared
Oct 27, 2023
GIA™ Stapler with Tri-Staple™ Technology
GAG
Stapler, Surgical
119d
Cleared
Oct 27, 2023
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
OLP
Over-the-counter Powered Light Based Laser For Acne
246d
Cleared
Oct 27, 2023
Plaxpot Multi Plasma
QVJ
Low Power Electrosurgical Devices For Skin Lesion Destruction
612d
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