(555 days)
The Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgical applications. This includes incision, excision, or coagulation of tissue.
Dual Hook Scalpel (fiberoptic delivery system)
The provided text is a 510(k) clearance letter from the FDA for a device called "Dual Hook Scalpel (Fiber Optic Delivery System)". This document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that are typically found in a clinical study report. Therefore, I cannot extract the requested information from this document.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.