FDA Review Panel · SU

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

18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4108 General & Plastic Surgery devices
3201–3225 of 4108
Cleared Sep 11, 2017
da Vinci Xi EndoWrist Instruments and Accessories
K170645 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 193d
Cleared Sep 11, 2017
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
K170644 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 193d
Cleared Aug 24, 2017
VenaCure EVLT NeverTouch Procedure Kit
K171921 · AngioDynamics, Inc.
GEX · Powered Laser Surgical Instrument · 58d
Cleared Aug 22, 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · Stryker Instruments
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 18d
Cleared Aug 22, 2017
GRAVITY™ Soft Tissue Repair System
K170642 · Wrightmedicaltechnologyinc
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 173d
Cleared Aug 17, 2017
DeRoyal Laprador Specimen Retrieval System
K171475 · Deroyal Industries, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Aug 02, 2017
AUTOCON III 400
K171717 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 54d
Cleared Jul 28, 2017
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
K171699 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 50d
Cleared Jul 11, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
K171908 · 3M Company
SEL · Securement Wound Dressing For Reduction Of Infection · 15d
Cleared Jun 13, 2017
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
K171426 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 29d
Cleared Jun 13, 2017
Sculpsure
K171111 · Cynosure, Inc.
PKT · Laser For Disruption Of Adipocyte Cells For Aesthetic Use · 60d
Cleared Jun 13, 2017
da Vinci Xi Surgical System
K170713 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 96d
Cleared Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K171066 · Covidien, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 59d
Cleared Jun 08, 2017
Novosyn Quick Absorbable Suture
K170661 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 97d
Cleared May 31, 2017
EndoWrist Stapler 45 System and Stapler 45 Reloads
K171388 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 20d
Cleared May 31, 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
K170278 · C.R. Bard, Inc.
GDW · Staple, Implantable · 121d
Cleared May 26, 2017
SutureTape
K171296 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 24d
Cleared May 26, 2017
da Vinci X Surgical System
K171294 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 24d
Cleared May 25, 2017
KARL STORZ ICG Imaging System
K171238 · KARL STORZ Endoscopy-America, Inc.
OWN · Confocal Optical Imaging · 28d
Cleared May 24, 2017
Cook Holmium Laser Fiber
K163197 · Cook Incorporated
GEX · Powered Laser Surgical Instrument · 190d
Cleared May 23, 2017
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc.
FRO · Dressing, Wound, Drug · 167d
Cleared May 15, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
K153410 · 3M Company
SEL · Securement Wound Dressing For Reduction Of Infection · 537d
Cleared May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
K163576 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 143d
Cleared May 05, 2017
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
K162449 · AngioDynamics, Inc.
NEY · System, Ablation, Microwave And Accessories · 246d
Cleared Apr 21, 2017
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
K170869 · Covidien
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices

Filter by Product Code

All categories 4108 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 497 GCJ Laparoscope, General & Plastic Surgery 334 FRO Dressing, Wound, Drug 163 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 118 GDW Staple, Implantable 107 NAY System, Surgical, Computer Controlled Instrument 99 FTL Mesh, Surgical, Polymeric 95 OMP Negative Pressure Wound Therapy Powered Suction Pump 93 KGN Wound Dressing With Animal-derived Material(s) 74 OAP Laser, Comb, Hair 72 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 71 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid 62 GEH Unit, Cryosurgical, Accessories 62