← Product Code [FFL](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL) · K970489

# COMEG ENDOSCOPY GRASPING FORCEPS (K970489)

_Comeg Endoscopy · FFL · Mar 19, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K970489

## Device Facts

- **Applicant:** Comeg Endoscopy
- **Product Code:** [FFL](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL.md)
- **Decision Date:** Mar 19, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4680
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **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.

## Regulatory 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)

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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.

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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.
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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K970489](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K970489)

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