Knife, Ear

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Shandong and Shanghai.

Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

What Is FDA Product Code JYO?

Knife, Ear is FDA product code JYO, Class 1, 21 CFR 874.4420.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Skull Base

Skull Base Round Knife Angled 45° Stainless Steel

Nasal Sickle Knife

Nasal Sickle Knife Straight Small Blade

Knife, Ear

Tympanoplasty Blade

Pilling

Catalogue number IPN002075, listed by Teleflex Medical LLC, United States, under Knife, Ear. 2 manufacturers in China are registered for this product code.

Medetz Surgical Instruments

Royce Ear Knife, 8mm, upcutting bld

Zoellner Micro Ear Knife

Zoellner Micro Ear Round Knife 45 Degree Angle Up

Buck Myringotomy Knife

Catalogue number 467-464, listed by Sontec Instruments, Inc., United States, under Knife, Ear. 2 manufacturers in China are registered for this product code.

Knife

EAR, Politzer, Angled

Gen2

House Lancet Knife

Plester First Incision Knife

Catalogue number 467-463, listed by Sontec Instruments, Inc., United States, under Knife, Ear. 2 manufacturers in China are registered for this product code.

Surgipros

Scalpel Myringotomy Knife 8MM, Straight, 6 1/2IN

Sexton EAR Knife

Sexton-Gerzog EAR Knife Straight Shaft

Endo-EAR

LEE No.6 Suction Dissector, 1.0 x 1.5mm, 1.0mm Suction to Tip

Wagner Hook

Wagner Hook Size 3

BR Surgical, LLC

HOUSE Incudostapedial Joint Knife, circular tip, octagonal handle, 0.75 mm diameter blade, angled 60 degrees, 6 1/2"

Bear

Tabb Double-Ended Flap Knife, 90 and 120 Deg. Blades

Bojrab Dissection Round Knife, 2.5MM DIA

Bojrab Dissection Round Knife Angled 45°, 2.5MM DIA., L 165MM

Millennium

House-Sheehy Knife Curette, 6 1/2", malleable, semi-sharp, large

Bojrab Dissection Sickle Knife

Bojrab Dissection Sickle Knife 6.35MM Curved Blade Stainless Steel

Jedmed

Suct Separator RND CUT 45-DEG 2.5MM

V. Mueller

Royce Tympanum Perforators Straight, Bayonet Vertical Spear Blade 5.2 X 2MM Wide Overall Length 7-1/8" (18.1CM)

Integra® Jarit®

Integra® Jarit® House Lancet Knife, "Number Two Knife", 6-3/4", 2x3mm Tapered Blade, Angled 45°

Novo Surgical Inc.

hough whirly-bird-style knife, 6" (15.0 cm), 1.0 mm x 5.0 mm blade, strong curve, #1, angled right

Gimmi

House Tympanoplasty Knife 7 MM, Curved Length 170 MM

Zoellner Micro EAR Sickle

Zoellner Micro EAR Sickle Knife Curved UP-Angle TIP

Politzer EAR Knife

Politzer EAR Knife Bayonet Shaft Arrow Blade

Integra® Miltex®

Integra® Miltex® House Incudostapedial Joint Knife 6", 0.75mm Diameter Blade, Angled 60°

Ambler Surgical

Myringotomy lance knife, juvenile size, straight, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

MSI Precision Specialty Instruments

Royce Ear Knife, Straight 7mm Up Cutting Blade, Bayonet, Flat Handle, Working Length 2-1/2" (63mm), Overall Length 7-1/3" (185mm)

Integra®

Integra® McCabe Flap Knife Dissector, Double Ended, Blades 2mm*3mm, 25 degree & 45 degree, 7-1/4"

Inka

HOUSE-PAPARELLA Incudostapedial Joint Knife blade 0.5x1.5mm 20°angled 16.5cm

Lucae Ear Hook

Lucae Ear Hook Fine Ball Tip Quantum

Bojrab Dissection Round Knife, 2.54MM DIA

Bojrab Dissection Round Knife Angled 35°, 2.54MM DIA. Stainless Steel

Bear

Shambaugh-Derlacki Elevator, Light Curve, 3.0mm Tip

Sklar

Plester Micro Flap Knife STR6 Inches

Medicon

Politzer (Royce) tympanum perforator 16cm ang

HNM Medical

House Incudostapedial Joint Knife, 6 1/2", 0.5MMX1.5MM Blade, ANG 20°

Bausch + Lomb

Perkins DIS 90 Degress-Modified

Novo Surgical

hough whirly-bird-style knife, 6" (15.0 cm), 0.5 mm x 5.0 mm blade, light curve, #3, angled right

V. Mueller

V. Mueller MCCABE FLAP KNIFE DISCT DBL-END, 2X3.5MM BLDES ANG 20DEG and 45DEG,SQUARE HOLLOW HNDL OVERALL LENGTH 7-1/4 inches 18.4CM

MicroFrance®

MicroFrance® Causse knife with bent shaft, 90 °, 3 mm blade, 165 mm length

Aesculap

Round Cutting Knife, 45 °, angled, 6 1/4" (160 mm), diam. 1,50 mm, slender pattern, round cutting

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer