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NY N016174

September 19, 2007



TARIFF NO.: 9018.19.4000, 9018.90.7580

Mr. Michael J. Skidmore, Customs Consultant 103 Greenleaf Street
Quincy, MA 02169

RE: The tariff classification of Medical Appliances from Germany

Dear Mr. Skidmore:

In your letter dated August 15, 2007 for Karl Storz Endoscopy America, Inc., you requested a tariff classification ruling. No sample was provided. However, you did send an un-annotated 30 to 50 page instruction manual for each item.

You state, “Calcusplit Model 276300 20 is a pneumatic lithotripter designed for intracorporeal lithotripsy. The unit operates by driving a projectile that is driven by compressed air. When the projectile hits the proximal end of the probe, the probe impacts the stone causing the stone to break. The waves are generated pneumatically using an invasive technique (direct contact to the stone, as opposed to extracorporeal shockwave lithotripsy where ultrasonic waves are delivered from outside the body.)

The Calcusplit is suitable for lithotripsy of lower ureteral and renal calculi. The Calcusplit is designed to be used ONLY with endoscopes. We suggest classification under HTS 9018.19.4000 given that it is designed for use only with endoscopes.”

You state, “The second item is a Mirco Hysteroflator model number 26431520. It is an electronic insufflation unit used in hysteroscopic interventions. It provides CO2 gas distension of the uterus for diagnostic hysteroscopy. It features a user adjustable flow rate of 0-100 ml/min and user adjustable insufflation pressures of 25-200mmHg. The user can monitor the insufflation parameters on the front panel indicators. The Hysteroflator monitors both pressure and flow rate, sounding an alarm and terminating the flow of gas if an overpressure situation is detected.

.We propose classification under HTS 9018.907580.

You state, “Item three is called a Clearvision II Lens Irrigation System, Part number 40334120. The unit is a lens irrigation pump for use in the fields of ENT and neurosurgery (Functional endoscopic sinus surgery and endoscopic transnasal pituitary gland surgery. The unit is used in conjunction with irrigation sheaths (not imported with the machine, but sold as accessories) for cleaning the distial lens (endoscope window). It is operated by a footswitch. It enables cleaning of the lens and removal of drops of liquid from the lens with only one irrigation/suctions channel. It does this by means of specific actuation of the pump top in an oscillation mode with the footswitch in position one. It can also be used in position two to operate on a continuous irrigation mode. When the footswitch is released, liquid is sucked back through the sheath.

.As this unit is used in conjunction with endoscopic surgery, we suggest classification as 9018.19.4000.

Regarding the Calcusplit, it is not an Apparatus for functional exploratory examination, as you propose, since its essential purpose is to break down the calculi, not provide diagnostic information. A laser lithotripter was classified in HTSUS 9018.90 in Headquarters Ruling Letter 951871, 8-18-92.

Regarding the Clearvision II, we note the irrigation and suction is used to clean the viewing lens of the endoscope itself, not any surgical instruments which may enter via a channel in it (as in Harmonized System Explanatory Note I-O to 9018).

  The applicable subheading for the Calcusplit and the Hysteroflator will be 9018.90.7580, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Electro-medical instruments and appliances and parts and accessories thereof. The rate of duty will be free.

We agree that the applicable subheading for the Clearvision II will be will be 9018,19.4000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Apparatus for functional exploratory examination and parts and accessories thereof. The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at 646-733-3012.


Robert B. Swierupski

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