Hook, Tonsil Suturing

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 KBP?

Hook, Tonsil Suturing is FDA product code KBP, 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.

Hook, Tonsil Suturing

Ambler Surgical

Boettcher tonsil hook, 8 1/4'', small, 2 sharp prongs, flat handle

Hook, Tonsil Suturing

V. Mueller

V. Mueller BOETTCHER TONSIL HOOK SHARP 2 LARGE PRONGS OVERALL LENGTH 8-1/4 inches 21CM

Hook, Tonsil Suturing

Medicon

Boettcher tonsil hook sh

Hook, Tonsil Suturing

Jedmed

Hook Sharp Back ACT 22CM Work Length

Hook, Tonsil Suturing

Who Makes This Device Type in China?

What Is FDA Product Code KBP?

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

Ambler Surgical

V. Mueller

Medicon

Jedmed

Where China Actually Supplies