HI-TEC CO2 INSUFFLATOR TYPE 1300

• K Number: K955477
• Device Name: HI-TEC CO2 INSUFFLATOR TYPE 1300
• Manufacturer: HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
• Date Cleared: 1997-08-06 ( 615 days)
• Product Code: HIF
• Regulation Number: 884.1730
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

CO2 Laparoscopic Insufflator type 1300

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a CO2 Laparoscopic Insufflator. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot answer the request based on the provided input.

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.