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Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.

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This document is a 510(k) clearance letter from the FDA for SureTek Medical's reprocessed laparoscopic instruments. It does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of an AI/ML medical device.

The letter confirms that the devices are substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the reprocessed devices are as safe and effective as existing ones, based on documentation submitted by SureTek Medical.

Therefore, I cannot extract the requested information as it is not present in the provided text.

The information provided is:

• Device Name: Suretek Reprocessed Laparoscopic Instruments
• Indications For Use: Intended for use during general and laparoscopic surgery for cutting, grasping, dissection, and electrocautery of tissue.
• Regulatory Clearance: 510(k) K052690, cleared on May 12, 2006, with supplemental validation data reviewed on October 16, 2006.
• Predicate Devices: The enclosure (not fully provided here, but the list of specific devices like "AUTOSUTURE ENDO DISSECT 5mm" are implicitly the reprocessed versions that were found substantially equivalent to original devices).

This document is focused on regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria in the way a new medical device would be evaluated for its efficacy or AI/ML algorithm's performance.

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