Chisel, Middle-Ear

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Shandong and Shanghai: 2 hold an FDA registration.

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

What Is FDA Product Code JYE?

Chisel, Middle-Ear is FDA product code JYE, Class 1, 21 CFR 874.4420.

What Does It Take to Sell It in the United States?

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.

Chisel, Middle-Ear

V. Mueller

V. Mueller HOUSE FOOT PLATE CHISEL MALLEABLE SHAFT, STRONG CURVE BLADE 0.5MM WIDE OVERALL LENGTH 6-1/4 inches 15.9CM

Chisel, Middle-Ear

Integra® Jarit®

Integra® Jarit® House Footplate Chisel, 6-1/2", Malleable, 2.4mm wide Tip

Chisel, Middle-Ear

Symmetry House

Symmetry® Chisel, House Foot Plate, 6 in

Chisel, Middle-Ear

Jedmed

Chisel Footplate House Straight TIP

Chisel, Middle-Ear

Pilling

Catalogue number IPN021081, listed by Teleflex Medical LLC, United States, under Chisel, Middle-Ear. 2 manufacturers in China are registered for this product code.

Chisel, Middle-Ear