CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF

• K Number: K992481
• Device Name: CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
• Manufacturer: WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
• Date Cleared: 2000-03-17 ( 235 days)
• Product Code: HET
• Regulation Number: 884.1720
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

The WISAP CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO2-Gas for diagnostic or operative Pelviscopy/Laparoscopy.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The documents are a 510(k) clearance letter and an indications for use statement for a medical device (WISAP CO2-OP-Pneu Computer). They confirm the FDA's regulatory approval but do not detail the specific performance acceptance criteria or the study data that led to this approval.

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.