Search Results

The Caldera Medical Benesta™ Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

Not Found

This document is an FDA 510(k) clearance letter for the Benesta™ Tissue Removal Device. It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The letter focuses on the regulatory aspects of the clearance, such as:

• Trade/Device Name: Benesta™ Tissue Removal Device
• Regulation Number: 21 CFR § 884.1690
• Regulation Name: Hysteroscope and Accessories
• Regulatory Class: II
• Product Code: HIH
• Indications for Use: Intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

To provide the information requested about acceptance criteria and a study proving device performance, you would need to refer to the 510(k) summary or the full 510(k) submission that was provided to the FDA by Caldera Medical, Inc. This public document (the clearance letter) confirms the regulatory status but does not typically detail the specific performance studies and acceptance criteria used for the clearance.

Ask a specific question about this device