(62 days)
The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.
The Interceptre™ Endoscopic instruments are a line of hand-held, non-sterile, reusable instruments
This document does not contain the information required to answer your request. The provided text is a 510k summary for "Interceptre™ Laparoscopic Instruments" and details administrative information, device description, and intended use. It does not include any acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth information typically associated with studies proving device performance, especially in the context of AI or advanced analytical devices.
{0}------------------------------------------------
... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..............................................................................................................
MAR | 8 |997
Section 7- 510k Summary of Safety and Effectiveness
| 7.1Statement | This summary of 510k safety and effectiveness information is being submitted inaccordance with the requirements of SMDA 1990 and CFR 807.92 |
|---|---|
| 7.2Submitter | Smith & Nephew, Inc., Endoscopy Division130 Forbes BoulevardMansfield, Ma. 02048 |
| 7.3CompanyContact | Susan FinneranClinical/ Regulatory Affairs(508) 261-3772 |
| 7.4DeviceName | Proprietary Name: Interceptre™ Laparoscopic InstrumentsCommon Name: Minimally Invasive Surgical Instruments: graspers, dissectors,scissors,Classification Name: Endoscopic accessories(78 GCJ)Laparoscopic accessories (85 HET)Electrosurgical accessories (79 BWA, 78 KNS) |
| 7.5PredicateLegallyMarketedDevices | Karl Storz Take-Apart Endoscopic Instruments Richard Wolf Laparoscopic Instruments Smith and Nephew Endoscopic Instruments |
| 7.6DeviceDescription | The Interceptre™ Endoscopic instruments are a line of hand-held, non-sterile,reusable instruments |
| 7.7Intended Use | The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, andscissors which are intended to be used to grasp, manipulate, cut, cauterize softtissue. |
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.