HI-FLO THERME PNEU 45, WISAP #7083, 7083V

• K Number: K031014
• Device Name: HI-FLO THERME PNEU 45, WISAP #7083, 7083V
• Manufacturer: WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
• Date Cleared: 2003-06-27 ( 88 days)
• Product Code: HIF
• Regulation Number: 884.1730
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a laparoscopic insufflator (HI-FLO Therme Pneu 45). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the given context.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.