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
4109 General & Plastic Surgery devices
3276–3300 of 4109
Cleared May 30, 2014
ULTRAPRO COMFORT PLUG
K133198 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 225d
Cleared May 13, 2014
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
K140343 · Aesculap, Inc.
MPN · Tissue Adhesive For The Topical Approximation Of Skin · 91d
Cleared Apr 28, 2014
CAIMAN SEAL AND CUT TECHNOLOGY
K140839 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 26d
Cleared Apr 17, 2014
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
K140495 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 49d
Cleared Mar 10, 2014
DERMABOND PRINEO SKIN CLOSURE SYSTEM
K133864 · Ethicon, Inc.
OMD · Cutaneous Tissue Adhesive With Mesh · 81d
Cleared Feb 28, 2014
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K132580 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 196d
Cleared Jan 30, 2014
ARTHREX BIOSUTURE
K140019 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 27d
Cleared Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
K132441 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 129d
Cleared Dec 06, 2013
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 36d
Cleared Dec 05, 2013
TFCC FAST-FIX KIT
K132079 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 153d
Cleared Dec 02, 2013
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc.
GDW · Staple, Implantable · 144d
Cleared Oct 30, 2013
SMITH & NEPHEW ULTRATAPE
K132357 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 93d
Cleared Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 78d
Cleared Oct 16, 2013
MEDLINE SUCTION COAGULATOR
K122949 · Medline Industries, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 387d
Cleared Oct 04, 2013
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc.
GAD · Retractor · 42d
Cleared Aug 09, 2013
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · Zimmer, Inc.
KCY · Tourniquet, Pneumatic · 263d
Cleared Jul 31, 2013
ARTHREX SPEEDCINCH
K132043 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 29d
Cleared May 22, 2013
H-30 HOLMIUM LASER SYSTEM
K130444 · Cook, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared May 17, 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976 · Aesculap, Inc.
MPN · Tissue Adhesive For The Topical Approximation Of Skin · 316d
Cleared May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 23d
Cleared Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
K130121 · Boston Scientific Corporation
GCJ · Laparoscope, General & Plastic Surgery · 84d
Cleared Mar 22, 2013
CAIMAN SEAL AND CUT TECHNOLOGY
K130596 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Feb 28, 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company
FRO · Dressing, Wound, Drug · 90d
Cleared Feb 05, 2013
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
K123114 · Ethicon, Inc.
GDW · Staple, Implantable · 125d
Cleared Jan 22, 2013
PERMASORB DISPOSABLE FIXATION DEVICE
K123718 · C.R. Bard, Inc.
GDW · Staple, Implantable · 49d

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All categories 4109 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 498 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