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

3451–3475 of 4109

Cleared Apr 01, 2004

K033337 · Ethicon, Inc.

FTL · Mesh, Surgical, Polymeric · 167d

Cleared Mar 25, 2004

TENDERWET ACTIVE

K040517 · Medline Industries, Inc.

MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 27d

Cleared Mar 01, 2004

BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007

K033814 · C.R. Bard, Inc.

FTL · Mesh, Surgical, Polymeric · 83d

Cleared Feb 25, 2004

SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975

K033981 · Smith & Nephew, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 64d

Cleared Feb 24, 2004

COBRA SURGICAL PROBE

K040219 · Boston Scientific Corp

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d

Cleared Feb 18, 2004

COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0

K040104 · Boston Scientific Corp

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d

Cleared Feb 04, 2004

MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT

K033652 · Zimmer, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 76d

Cleared Jan 14, 2004

ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239

K032245 · Arthrex, Inc.

GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 176d

Cleared Dec 18, 2003

MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE

K033746 · Ethicon, Inc.

GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 17d

Cleared Dec 01, 2003

AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT

K032696 · United States Surgical, A Division of Tyco Healthc

GDW · Staple, Implantable · 90d

Cleared Nov 17, 2003

CAPROSYN ABSORBABLE SUTURE

K032586 · United States Surgical, A Division of Tyco Healthc

GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 87d

Cleared Oct 22, 2003

MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE

K032420 · Ethicon, Inc.

GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 78d

Cleared Oct 07, 2003

3M LIQUID BANDAGE, MODEL 120-LB

K031263 · 3M Company

KMF · Bandage, Liquid · 169d

Cleared Sep 26, 2003

SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045

K032680 · Smith & Nephew, Inc.

GCJ · Laparoscope, General & Plastic Surgery · 28d

Cleared Sep 17, 2003

PROCEED TRILAMINATE SURGICAL MESH

K031925 · Ethicon, Inc.

FTL · Mesh, Surgical, Polymeric · 86d

Cleared Sep 05, 2003

ENDOSCOPIC APPLICATOR

K031882 · Baxter Healthcare Corp

GCJ · Laparoscope, General & Plastic Surgery · 79d

Cleared Aug 20, 2003

COBRA COOLED SURGICAL PROBE, MODEL M004159670

K032207 · Boston Scientific Corp

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 33d

Cleared Aug 08, 2003

CARDIOVATIONS PORTABLE VIDEO SYSTEM

K032339 · Ethicon, Inc.

GCJ · Laparoscope, General & Plastic Surgery · 10d

Cleared Jul 28, 2003

DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

K031969 · DePuy Orthopaedics, Inc.

FTM · Mesh, Surgical · 32d

Cleared Jul 21, 2003

CARDIOVATIONS RETRACTOR

K031847 · Ethicon, Inc.

GCJ · Laparoscope, General & Plastic Surgery · 35d

Cleared Jul 21, 2003

CARDIOVATIONS OPTICAL BIPOLAR DEVICE

K031846 · Ethicon, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 35d

Cleared Jul 17, 2003

CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM

K031247 · Medtronic Vascular

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d

Cleared Jun 20, 2003

SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR

K031675 · Smith & Nephew, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 21d

Cleared May 29, 2003

SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE

K031286 · Aesculap, Inc.

GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 36d

Cleared May 23, 2003

SAPHYRE BIPOLAR ABLATION PROBES

K031371 · Smith & Nephew, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d

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