(197 days)
Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
Semkin Insulated Bipolar Forcep
The provided document is a 510(k) clearance letter from the FDA for the Semkin Insulated Bipolar Forcep. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter only states that the device is substantially equivalent to legally marketed predicate devices for its intended use, which is "Intended to remove tissue and control bleeding by use of high frequency electrical current." It also mentions general controls provisions and compliance with Good Manufacturing Practice.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from this document. This typically would be found in the 510(k) summary or a more detailed technical submission, which is not provided here.
§ 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.