PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE

K960299 · Richard Wolf Medical Instruments Corp. · HET · Oct 28, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960299
• Device Name: PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Indications for Use

The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures.

Device Story

Pyramidal trocar with spring-return protective sleeve; used for establishing surgical access by piercing vessels or chambers; facilitates insertion of cannula for diagnostic/therapeutic measures; operated by surgeons in clinical/OR settings; protective sleeve shields tip post-introduction to prevent accidental injury; device provides physical access path for endoscopic instruments.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: medical grade stainless steel and brass (satin chrome-plated). Design: pyramidal tip with spring-return protective sleeve mechanism for shielding.

Indications for Use

Indicated for patients requiring surgical access to vessels or body chambers for diagnostic or therapeutic procedures.

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.

Submission Summary (Full Text)

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OCI-22-1330 11:41

Richard Wolf Medical Instruments Corporation

353 Corporate Woods Parkway

Vernon Hills, Illinois 60061

Telephone: [phone]

Fax: [phone]

OCT 28 1996

K960299

p142

# 510(k) Summary of Safety and Effectiveness

1.0 Classification Name: Trocar and Trocar sleeve
2.0 Common/Usual Name: Trocar and Trocar sleeve
3.0 Trade Name: Pyramidal Trocar with spring-return protective sleeve
4.0 Equivalence: These devices are equivalent to existing Richard Wolf Pre-enactment Devices and substantially equivalent to existing competitor devices on the market today.
5.0 Description: Trocars are made of medical grade stainless steel and brass (satin chrome-plated).
6.0 Intended Use: The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures.
7.0 Technological Characteristics: The trocar was specially designed to shield the tip from exposure after introduction.
8.0 Performance Data: Trocars have been tested and found to be safe when used in accordance with the intended use as outlined in the Instruction for Use Manual.
9.0 Clinical Tests: No clinical tests performed.

RICHARD WOLF

{1}

0C1-22-1000 1141

# Richard Wolf Medical Instruments Corporation

K960299
P2012

## 10.0 Data Conclusion

Trocars from Richard Wolf are substantially equivalent to existing instruments on the market.

By: Robert L. Casarsa
Quality Assurance Manager
Date: October 22, 1996

TOTAL P.03