Resectoscope

Who Makes This Device Type in China?

The one Chinese manufacturer registered for this device type is based in Jiangsu. 1 is a contract manufacturer.

Peter's Technology (Suzhou) Co., Ltd. Jiangsu, contract manufacturer

How Is FJL Classified?

Resectoscope is FDA product code FJL, Class 2, 21 CFR 876.1500.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 33 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Packaging (12), Process control (1) and Packaging process control (1).

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

Olmypus

Inner sheath, long, for WA22018A and WA22019A

Gyrus Acmi

High Frequency Cable, ERBE ACC/ICC

Panoview Plus

TELESCOPE 25° Ø 4MM WL 342MM rigid, TL 404mm, rod lens system

Veloxion

Veloxion Fluid Control Set

Gimmi

Monopolar Resectoscope Electrode Loop, Angled, FOR 30° Scope, Single USE FOR 26 / 24 CH Resectoscope Sheath

Urology Evacuator

7 catalogue numbers from 195 090 500, listed by Sopro-Comeg GmbH, Germany, under Resectoscope. 1 manufacturer in China is registered for this product code.

Panoview

MORCESCOPE 12° 24.5FR WL 199MM rigid, with parallel ocular lens, working channel for instruments up to 4.8mm, irrigation via 24.5/26Ch sheath and attachement, suction via morcellator, TL…

Urology Syringe

15 catalogue numbers from 395 015 032, listed by Sopro-Comeg GmbH, Germany, under Resectoscope. 1 manufacturer in China is registered for this product code.

Olympus

Inner sheath, long, for WA22018A/19A, with deflecting tip obturator

Veress Insufflation Needle

3 catalogue numbers from 391 020 060, listed by Sopro-Comeg GmbH, Germany, under Resectoscope. 1 manufacturer in China is registered for this product code.

Midi-Size

OBTURATOR RESECTOSCOPE 14.5FR color code white, WL 240 mm, oval, rounded distal end, compatible with sheath 86770155, reusable

Shark

SHEATH RESECTOSCOPE 26FR color code black, SL 201 mm, round, rotatable, slanted distal end, ceramic, intermittent flushing, compatible with Shark irrigation adaptor 8676354 or 8676361, and…

Piranha

MORCELLATOR BLADE LONG Ø 4.8MM WL 385MM for Morcescope, PACK = 3 pcs., for morcellation following laser prostate enucleation, sterile

Resectoscope

Inner Sheath,with 7.5Fr. working channel

Resection Master

OUTER SHEATH RESECTOSCOPE 27FR color code yellow, WL 184mm, round, distal end straight, compatible with outer sheath 8659071 for Resection Master Resectoscope 27Fr with integrated chip…

Resectoscope

SHEATH FOR URETERAL RESECTOSCOPE 11.5FR SL 405mm, round, fixed irrigation tap, distal end straight, intermittent flushing, compatible with telescope 8720401 Ø 2.2/2.7mm, 0°, quick-lock,…

E-Line

INTERNAL SHEATH RESECTOSCOPE 24FR color code yellow, SL 208mm, round, rotatable irrigation ring, slanted distal end, ceramic, continuous irrigation, compatible with outer sheath 8655074,…

AED

Resectoscope sheath for continuous irrigation with standard obturator with central valve 27 CH

Ureterorenoscope

28 catalogue numbers from 185 900 000BC001, listed by Sopro-Comeg GmbH, Germany, under Resectoscope. 1 manufacturer in China is registered for this product code.

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