(37 days)
The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.
The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.
The provided text is a summary of safety and effectiveness for grasping forceps (K970489) and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/algorithm performance. It primarily focuses on the regulatory submission details for a medical device (grasping forceps) in 1997, comparing it to a legally marketed substantially equivalent device.
Therefore, I cannot extract the requested information based on the provided input. The document describes a medical device and its intended use, rather than a study evaluating device performance against acceptance criteria using expert-reviewed data.
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ID:303-617-7929
Image /page/0/Picture/2 description: The image contains the words COMEG ENDOSCOPY. The words are written in a sans-serif font. The word COMEG is also written in a larger font in the middle of the image, inside of a black rectangle.
MAR 1 9 1997
K 970489
p192
SUMMARY OF SAFETY AND EFFECTIVENESS FOR GRASPING FORCEPS
6807.92 (a)(1)
Contact Person:
Peter Dufly Vice President
Date of Summary Preparation; March 19, 1997
8807.92 (a)(2)
COMEG Endoscopy Grasping Forceps Trade Name:
Cominon Name: Stone dislodger
Classification Name: Ureteral stonc dislodger (21 CFR §876.4680)
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Karl Storz Grasping forceps for removal of foreign bodies
$807.92 (a)(4)
Description of Device:
The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.
8807.92 (a)(5)
Intended Use:
The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.
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Image /page/1/Picture/3 description: The image shows the word "COMEG" in a bold, sans-serif font. The letters are white and the background is black. The letters appear to be stenciled, with some breaks in the solid white fill.
e n d o s c o p y
K970489
P2092
page 2- Summary of Safety and Effectiveness for Grasping Forceps
§807.92 (a)(6)
Comparison of Technical Characteristics; The subject and predicate devices are similar in diameter, length, material, tip configuration, and tip action.
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.