Trocar, Gastro-Urology

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.

Hangzhou Endo Medical Instrument Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code FBQ?

Trocar, Gastro-Urology is FDA product code FBQ, Class 2, 21 CFR 876.5090.

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 Has Gone Wrong With It?

The FDA has recorded 25 recalls under this product code since 2022. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Trocar, Gastro-Urology

Hopkins

Compact Cysto-Urethroscope, 24 Fr.

Trocar, Gastro-Urology

Vario-Port

REDUCTION ADAPTER for reduction from Ø 7mm, Ø 10mm and Ø 12.5 to Ø 5.5mm for RIWO-ART trocars, PACK=5 PCS, reusable

Trocar, Gastro-Urology

Baltaxe-Mitty-Pollack

Disposable Baltaxe-Mitty-Pollack Coaxial Needle Set

Trocar, Gastro-Urology

Busse Hospital Disposable

4.5MM Pellet Insertion Tray with Medium Gloves

Trocar, Gastro-Urology

Trotec

SHEATH W. TROCAR TIP SZ 12.5MM WL 181MM distal tip two-sided, with automatic protection function, reusable

Trocar, Gastro-Urology

Busse Hosptial Disposables

Pellet Insertion Tray

Trocar, Gastro-Urology

Mitty-Pollack

Echotip, Mitty-Pollack Needle Set

Trocar, Gastro-Urology

Busse Hospital Diposables

SS 3.5MM Pellet Insertion Tray with Large Gloves

Trocar, Gastro-Urology

Integra® Miltex®

DUKE Trocar and Cannula

Trocar, Gastro-Urology

Cook

Disposable Two-Part Trocar Needle

Trocar, Gastro-Urology

Spring Grip

Anchoring Device

Trocar, Gastro-Urology

Strauss Surgical

3 catalogue numbers from STS-LAP-121-11, listed by American Medical Endoscopy, United States, under Trocar, Gastro-Urology. 1 manufacturer in China is registered for this product code.

Trocar, Gastro-Urology

EchoTip

Echotip, Disposable Two-Part Trocar Needle

Trocar, Gastro-Urology

Busse Hospital Disposables

4.5MM SS Diamond Tip Trocar Tray with oversized Cannula and medium gloves

Trocar, Gastro-Urology

Trocar, Gastro-Urology

TROCAR SLEEVE FLEX CAP 10MM WL 56MM color code red orange, PACK=1 PC, ribbed plastic sleeve, distal tip straight, with universal sealing valve, without insufflation stopcock, reusable

Trocar, Gastro-Urology

Mitty

Mitty Needle

Trocar, Gastro-Urology

Trocar, Gastro-Urology

SCHMIEDT Visual Obturator, 24/26 Fr.

Trocar, Gastro-Urology

Riwo-ART

TROCAR SLEEVE STRAI. CAP 10MM WL 100MM stainless steel-sheath tube smooth, distal tip straight, with Magnet-ball valve, with high-flow insufflation hose connection, reusable

Trocar, Gastro-Urology

MIP Minimal Invasive Pcnl

Operating Sheath for Supine Position

Trocar, Gastro-Urology

Doctor Nice

Reusable Trocar, gastro-urology 3.5mm, complete Set, 1 cannula, 1 blunt obturator and 1 sharp obturator Item number 786-28, SS

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