CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS

• K Number: K972719
• Device Name: CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
• Manufacturer: MEDICEL, S.A. DE C.V.
• Date Cleared: 1999-02-04 ( 563 days)
• Product Code: KCT
• Regulation Number: 880.6850
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Claricel sterilization pouches and reels are indicated to enclose another medical device that is to be steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 or ST-41 sterilization recommendations.

Device Description

Claricel Sterilization Pouches and Reels

AI/ML Overview

This is a 510(k) premarket notification for "Claricel sterilization pouches and reels". The provided text is a letter from the FDA determining substantial equivalence, along with the Indications For Use statement. It does not contain specific details about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance data from a specific study designed to meet acceptance criteria.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).