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

7738 General & Plastic Surgery devices

6851–6875 of 7738

Cleared Jun 20, 1985

VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR

K851769 · Artiberia

HTD · Forceps · 56d

Cleared Jun 20, 1985

13-530 TO 13-542 VARIOUS IRIS SCISSORS

K851767 · Artiberia

Cleared Jun 20, 1985

13-470 TO 13-518 VARIOUS UTERINE SCISSORS

K851766 · Artiberia

Cleared Jun 20, 1985

13-440 TO 13-464 VARIOUS DISSECTING SCISSORS

K851765 · Artiberia

Cleared Jun 20, 1985

13-340,13-350,13-360 LIGATURE SCISSORE SPENCER/LIT

K851764 · Artiberia

Cleared Jun 20, 1985

13-290 VARIOUS TONSIL SCISSORS-STRULLY, YANKAUER,

K851762 · Artiberia

Cleared Jun 20, 1985

13-280 NEURO SCISSORS

K851761 · Artiberia

Cleared Jun 20, 1985

13-270 KILNER SCISSORS

K851760 · Artiberia

Cleared Jun 20, 1985

13-260 TWO SIZES OF JOSEPH SCISSORS

K851759 · Artiberia

Cleared Jun 20, 1985

13-224 TO 13-258 VARIOUS METZENBAUM SCISSORS

K851758 · Artiberia

Cleared Jun 20, 1985

13-220 TOW TYPES OF LEXER SCISSORS

K851757 · Artiberia

Cleared Jun 20, 1985

13-180 TO 13-212 VARIOUS MODELS OF MAYO SCISSORS

K851756 · Artiberia

Cleared Jun 20, 1985

13-170 DEAVER SCISSOR, TWO SIZES

K851755 · Artiberia

Cleared Jun 20, 1985

13-160 INCISION SCISSORS, TWO SIZES

K851754 · Artiberia

Cleared Jun 20, 1985

13-100 TO 13-158 VARIOUS TYPES OF OPERATING SCISSO

K851753 · Artiberia

Cleared Jun 20, 1985

9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS

K851752 · Artiberia

GDN · Knife, Amputation · 56d

Cleared Jun 20, 1985

7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1

K851751 · Artiberia

GDX · Scalpel, One-piece · 56d

Cleared Jun 20, 1985

7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7

K851750 · Artiberia

GDZ · Handle, Scalpel · 56d

Cleared Jun 18, 1985

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG

K850018 · Laserscope

GEX · Powered Laser Surgical Instrument · 167d

Cleared Jun 12, 1985

SURGICAL STARTER KIT

K852112 · Devon Industries, Inc.

Cleared Jun 12, 1985

VALTRAC PURSESTING DEVICE

K851452 · Davis & Geck, Inc.

HCF · Instrument, Ligature Passing And Knot Tying · 62d

Cleared Jun 07, 1985

WECK LX TM SKIN STAPLER

K851258 · Edward Weck, Inc.

GAG · Stapler, Surgical · 71d

Cleared Jun 05, 1985

J & J ULCER DRESSING

K850451 · Johnson & Johnson Professionals, Inc.

FRO · Dressing, Wound, Drug · 119d

Cleared Jun 04, 1985

ELECTRO-CAUTERY KNIFE CLEANER 6000 1

K852184 · Dlp, Inc.

HAM · Apparatus, Electrosurgical · 15d

Cleared Jun 04, 1985

ECONOMY 400 CWS WITH PVC DRAINS

K851084 · C.R. Bard, Inc.

GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered · 78d

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