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
3501–3525 of 4109
Cleared Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 63d
Cleared Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 28d
Cleared Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation
FTD · Lamp, Surgical · 76d
Cleared Nov 01, 2001
KSEA SIALOENDOSCOPES AND ACCESSORIES
K012527 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 87d
Cleared Oct 04, 2001
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 34d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
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 06, 2001
VERASTEP
K012539 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 30d
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 13, 2001
MEDLINE GROUNDING PAD
K011515 · Medline Industries, Inc.
JOS · Electrode, Electrosurgical · 57d
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 May 14, 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 69d
Cleared May 03, 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · Biomet, Inc.
NEU · Marker, Radiographic, Implantable · 87d
Cleared May 02, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 86d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 46d
Cleared Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 49d
Cleared Apr 04, 2001
IVS TUNNELLER
K010035 · United States Surgical, A Division of Tyco Healthc
FTL · Mesh, Surgical, Polymeric · 90d
Cleared Mar 16, 2001
MRI SAFE INSTRUMENTS
K003965 · Aesculap, Inc.
GEA · Cannula, Surgical, General & Plastic Surgery · 84d
Cleared Feb 28, 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
K010444 · C.R. Bard, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Jan 29, 2001
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · STERIS Corporation
FST · Light, Surgical, Fiberoptic · 70d
Cleared Dec 27, 2000
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc.
FTM · Mesh, Surgical · 203d

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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