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

18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7697 General & Plastic Surgery devices
4526–4550 of 7697
Cleared Sep 19, 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · Aesculap, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 68d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Sep 10, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K011841 · Karl Storz Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Sep 07, 2001
CYNOSURE ACCLAIM DERMATOLOGY LASER
K011828 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Sep 06, 2001
VERASTEP
K012539 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 30d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · Cook, Inc.
NGU · Balloon, Liver Tamponade · 203d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc.
FZP · Clip, Implantable · 43d
Cleared Aug 30, 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488 · Endius, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Aug 30, 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · AtriCure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · Ortho Development Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d
Cleared Aug 22, 2001
RADIOGRAPHIC MARKERS
K011856 · Encore Orthopedics, Inc.
NEU · Marker, Radiographic, Implantable · 70d
Cleared Aug 09, 2001
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 83d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 89d
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219 · Aesculap, Inc.
HBO · Clip, Scalp · 15d
Cleared Jul 24, 2001
INTUITIVE SURGICAL ULTRASONIC SHEARS
K011281 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 88d
Cleared Jul 19, 2001
ENDOPOUCH RETRIEVER
K011501 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 64d
Cleared Jul 19, 2001
ENTEC EVAC PLASMA WAND
K011279 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 83d
Cleared Jul 13, 2001
MEDLINE GROUNDING PAD
K011515 · Medline Industries, Inc.
JOS · Electrode, Electrosurgical · 57d
Cleared Jul 13, 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 80d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 56d
Cleared Jun 28, 2001
MODIFICATION TO KSEA ENDOTIP SYSTEM
K011359 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 56d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 80d
Cleared Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · Arthrocare Corp.
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
K010870 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 87d

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All categories 7697 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 101 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 KGN Wound Dressing With Animal-derived Material(s) 85 LFL Instrument, Ultrasonic Surgical 85 GEH Unit, Cryosurgical, Accessories 78