Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.
This document is a 510(k) summary for surgical instruments and does not contain information about acceptance criteria or a study proving device performance as might be found for a diagnostic or AI-driven device. It focuses on demonstrating substantial equivalence to previously cleared devices. Therefore, I cannot extract the requested information from this text.
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MAR 12 1996
195400
510(k) Summary
Submitter:
Deknatel Snowden Pencer (DSP) 5175 South Royal Atlanta Drive Tucker, GA 30084 Phone: (770) 496-0952 Fax: (770) 934-8659 Contact: Julie A.K. Stephens
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Trade Name Diamond-Touch® and Micro Diamond-Touch® Instruments; Diamond-Line® Instruments; Diamond Port (Access Ports); Endo CABG (TM Approval Pending); CARDIO Port (TM Approval Pending)
Common Name - Endoscope and Accessories for Minimally Invasive Cardiovascular Surgery Classification Name - Endoscope and Accessories (per 21 CFR 876.1500) -
Equivalent Device Snowden-Pencer 510(k) # K930666 Reusable Laparoscopic/Endoscopic Surgical Instruments with Electrosurgical Connections and Accessories and Snowden-Pencer 510(k) # K930667 -- Reusable Laparoscopic Surgical Instruments for General Surgery, and Plastic and Reconstructive Surgery, Including Aesthetic Surgery
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Device Description The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.
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Intended Use Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
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Summary of Technical Characteristic Equivalence The endoscopes and endoscopic surgical instruments for cardiac procedures will use equivalent materials (such as stainless steel. titanium, rigid and flexible plastics, and insulation) and use the same designs (same handles, tubes, and jaws) as our current marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments.
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Summary of Performance Equivalence The endoscopes and endoscopic surgical instruments for cardiac procedures will have equivalent performance standards to our currently marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments.
Exhibit 2 - Page 1 of 1
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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 § 876.9.