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The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.

As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.

PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece

It appears the provided document is a 510(k) clearance letter from the FDA for a medical device called "PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece". This type of document does not typically include detailed information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical performance data that would involve detailed acceptance criteria and studies as requested in the prompt. While some 510(k) submissions might include performance testing, the provided letter itself does not contain that information.

Therefore, I cannot provide the requested information based on the given text. The text only states that the device is "substantially equivalent" to predicate devices and provides its intended use.

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