Gouge, Nasal, Ent

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

How Is KAQ Classified?

Gouge, Nasal, Ent is FDA product code KAQ, 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.

Gouge, Nasal, Ent

Bausch + Lomb

Putterman Consecutive Cdcr SE

Gouge, Nasal, Ent

Integra®

Integra® Parkes Hump Gouge

Gouge, Nasal, Ent

V. Mueller

V. Mueller PARKES HUMP GOUGE STRAIGHT OUTSIDE JAW 10MM WIDE OVERALL LENGTH 7" (17.8CM)

Gouge, Nasal, Ent

HNM Medical

West Lacrimal, 7 1/2"

Gouge, Nasal, Ent

Jedmed

Gouge Parkes Double Guard

Gouge, Nasal, Ent

Integra® Jarit®

Integra® Jarit® Andrew Mastoid Gouge, 6", 10mm Wide, Straight

Gouge, Nasal, Ent

Alexander Mastoid Gouge

Alexander Mastoid Gouge 2.0 Millimeter

Gouge, Nasal, Ent

Gouge

Septum, Killian Claus, V Shape, 5 MM TIP

Gouge, Nasal, Ent

Novo Surgical Inc.

bishop gouge, straight, 5.0 mm wide, 5 7/8" (15.0 cm)

Gouge, Nasal, Ent

Novo Surgical

zenith parkes hump gouge, 6.0 mm wide, double guarded, 7" (17.5 cm)

Gouge, Nasal, Ent

Millennium

Hibbs Gouge, 9 1/2", curved, 3/8"

Gouge, Nasal, Ent

MicroFrance®

MicroFrance® Fleury gouge, 2 mm, 130 mm length

Gouge, Nasal, Ent

Sontec Micro Gouge

4 catalogue numbers from 475-804, listed by Sontec Instruments, Inc., United States, under Gouge, Nasal, Ent. 2 manufacturers in China are registered for this product code.

Gouge, Nasal, Ent

Ambler Surgical

Killian-Claus septum gouge, 6 3/4'', bayonet shaft, straight, 6.0mm wide blade, with notch, square handle

Gouge, Nasal, Ent

Who Makes This Device Type in China?

How Is KAQ Classified?

How Does It Reach the US Market?

Where China Actually Supplies