(75 days)
Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, during the first 14 days following surgery and helps prevent obstruction by adhesions.
Sphenoid Sinus Stent
This document is a 510(k) clearance letter from the FDA for the Micromedics Sphenoid Sinus Stent. It primarily establishes substantial equivalence to a predicate device and outlines regulatory compliance requirements. It does not contain the acceptance criteria, study details, or performance data asked for in the prompt.
Therefore, an answer fulfilling all requirements of the prompt cannot be generated from the provided text. The document acts as a regulatory approval, not a scientific study report.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.