CORING MORCELLATOR

K960262 · Cook Urological, Inc. · HET · Apr 15, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960262
• Device Name: CORING MORCELLATOR
• Applicant: Cook Urological, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Coring Morcellator is used during laparoscopic surgery for the removal of a non-malignant fibroid tumor or other tissue within the peritoneal cavity.

Device Story

Coring Morcellator; manual surgical instrument used during laparoscopic procedures; removes non-malignant fibroid tumors or tissue from peritoneal cavity; stainless steel construction; operated by gynecological surgeons; facilitates tissue extraction through small laparoscopic incisions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Stainless steel construction; manual laparoscopic instrument; standard sterilization and packaging procedures.

Indications for Use

Indicated for removal of non-malignant fibroid tumors or other tissue during laparoscopic surgery within the peritoneal cavity.

Regulatory Classification

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.

Predicate Devices

• Serrated Edged Macro Morcellator (S*E*M*M*-Set) (Wisap)
• Birtcher Endoscopic Corkscrew (Birtcher Electro Medical Systems)

Submission Summary (Full Text)

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K960262
10

510(k) Premarket Notification
Coring Morcellator
Cook OB/GYN

# I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 15 1996

## Submitted By:

Tammy Bacon
Cook OB/GYN
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
January 17, 1996

## Device

Trade Name: Coring Morcellator
Proposed Classification Name: Laparoscope, Gynecologic (and Accessories)

## Predicate Devices:

The Coring Morcellator is substantially equivalent to other predicate devices in terms of indications for use and technology. Predicate devices include the Serrated Edged Macro Morcellator (S*E*M*M*-Set) manufactured by Wisap and the Birtcher Endoscopic Corkscrew manufactured by Birtcher Electro Medical Systems.

## Device Description:

The Coring Morcellator is used during laparoscopic surgery for the removal of a non-malignant fibroid tumor or other tissue within the peritoneal cavity. This device will be made from stainless steel. Stainless steel is widely accepted in the medical field, therefore, biocompatibility is assured.

## Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.