COMEG ENDOSCOPY GRASPING FORCEPS

K970489 · Comeg Endoscopy · FFL · Mar 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970489
• Device Name: COMEG ENDOSCOPY GRASPING FORCEPS
• Applicant: Comeg Endoscopy
• Product Code: FFL · Gastroenterology, Urology
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4680
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

COMEG Endoscopy Grasping Forceps; stainless steel surgical instruments; 7 and 9 French diameters; 40 cm length; alligator jaw with double action mechanism. Used in urological procedures by physicians to endoscopically grasp, manipulate, or remove calculi and foreign bodies. Device provides mechanical assistance for stone retrieval; enhances procedural efficiency; minimizes tissue trauma during foreign body extraction.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence established through comparison of physical and functional characteristics.

Technological Characteristics

Materials: Stainless steel. Configuration: 7 and 9 French diameters, 40 cm length. Mechanism: Double action alligator jaw. Energy source: Manual/mechanical. Sterilization: Not specified.

Indications for Use

Indicated for use in urological procedures for endoscopic removal, manipulation, or grasping of calculi (stones) and foreign objects in patients requiring such intervention.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Karl Storz Grasping forceps for removal of foreign bodies

Submission Summary (Full Text)

{0}

COMEG ENDOSCOPY
ID:303-617-7929
MAR 19'97 11:21 No.004 P.09
COMEG
Endoscopy
MAR 19 1997
K 970489
p192

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR GRASPING FORCEPS

§807.92 (a)(1)

Contact Person: Peter Duffy
Vice President

Date of Summary Preparation: March 19, 1997

§807.92 (a)(2)

Trade Name: COMEG Endoscopy Grasping Forceps

Common Name: Stone dislodger

Classification Name: Ureteral stone 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.

§807.92 (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.

-10-

{1}

COMEG ENDOSCOPY ID:303-617-7929 MAR 19'97 11:22 No.004 P.10
COMEG
Endoscopy
K970489
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.
-11-