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

18327

Total

18282

Cleared

139d

Avg (2y)

1976

Since

14267 General & Plastic Surgery devices

12951–12975 of 14267

Cleared Jun 26, 1985

ACKRAD SIALOGRAPHY CATHETER

K852154 · Ackrad Laboratories

Cleared Jun 26, 1985

STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE

K852202 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 36d

Cleared Jun 26, 1985

SURE-COUNT 15 COUNT NEEDLE COUNTER

K852257 · Kleen Test Products

Cleared Jun 20, 1985

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

K851750 · Artiberia

GDZ · Handle, Scalpel · 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

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

K851752 · Artiberia

GDN · Knife, Amputation · 56d

Cleared Jun 20, 1985

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

K851753 · Artiberia

Cleared Jun 20, 1985

13-160 INCISION SCISSORS, TWO SIZES

K851754 · Artiberia

Cleared Jun 20, 1985

13-170 DEAVER SCISSOR, TWO SIZES

K851755 · Artiberia

Cleared Jun 20, 1985

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

K851756 · Artiberia

Cleared Jun 20, 1985

13-220 TOW TYPES OF LEXER SCISSORS

K851757 · Artiberia

Cleared Jun 20, 1985

13-224 TO 13-258 VARIOUS METZENBAUM SCISSORS

K851758 · Artiberia

Cleared Jun 20, 1985

13-260 TWO SIZES OF JOSEPH SCISSORS

K851759 · Artiberia

Cleared Jun 20, 1985

13-270 KILNER SCISSORS

K851760 · Artiberia

Cleared Jun 20, 1985

13-280 NEURO SCISSORS

K851761 · Artiberia

Cleared Jun 20, 1985

13-290 VARIOUS TONSIL SCISSORS-STRULLY, YANKAUER,

K851762 · Artiberia

Cleared Jun 20, 1985

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

K851764 · Artiberia

Cleared Jun 20, 1985

13-440 TO 13-464 VARIOUS DISSECTING SCISSORS

K851765 · Artiberia

Cleared Jun 20, 1985

13-470 TO 13-518 VARIOUS UTERINE SCISSORS

K851766 · Artiberia

Cleared Jun 20, 1985

13-530 TO 13-542 VARIOUS IRIS SCISSORS

K851767 · Artiberia

Cleared Jun 20, 1985

VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR

K851769 · Artiberia

HTD · Forceps · 56d

Cleared Jun 20, 1985

VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA

K851770 · Artiberia

HTD · Forceps · 56d

Cleared Jun 20, 1985

15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST

K851771 · Artiberia

GEN · Forceps, General & Plastic Surgery · 56d

Cleared Jun 20, 1985

17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS

K851772 · Artiberia

GEN · Forceps, General & Plastic Surgery · 56d

Cleared Jun 20, 1985

17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI

K851773 · Artiberia

GEN · Forceps, General & Plastic Surgery · 56d

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