APPLIED MEDICAL CLIP APPLIER

K964470 · Applied Medical Resources · FZP · Jan 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964470
• Device Name: APPLIED MEDICAL CLIP APPLIER
• Applicant: Applied Medical Resources
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Applied Medical Clip Applier is a sterile single use device intended for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Device Story

Manual surgical instrument; single-use; sterile. Components: molded plastic handle, actuating trigger, 360° rotational shaft, applicator jaws. Pre-loaded with 20 implantable clips. Operation: surgeon triggers jaws to place clip on vessel/tubular structure. Features: clear distal tip for color-coded visual indication of final four clips; lockout mechanism activates after final clip release to neutralize jaws and prevent accidental tissue trauma. Used in OR for laparoscopic and general surgery. Benefits: secure vessel ligation; prevents accidental injury post-clip depletion.

Clinical Evidence

Bench testing only. Functional performance and biocompatibility tests performed to verify structural integrity and material safety.

Technological Characteristics

Manual surgical instrument. Materials: molded plastic handle, clear distal tip. Energy source: manual mechanical actuation. Form factor: handheld, 360° rotational shaft. Sterilization: sterile, single-use. No software or electronic components.

Indications for Use

Indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• LIGACLIP™ ERCA Clip Applier (Ethicon)

Submission Summary (Full Text)

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196440

JAN 22 1997

# APPENDIX VIII

## 510(k) SUMMARY

### 510(k) NUMBER:
PENDING

### SUBMITTED BY:
Applied Medical Resources Corporation
26051 Merit Circle, Unit# 103
Laguna Hills, California 92653
[phone] Ext. 310

### CONTACT PERSON:
Howard V. Rowe

### DATE OF PREPARATION:
November 5, 1996

### NAME OF DEVICE:
Applied Medical Clip Applier

### CLASSIFICATION NAME:
Manual Surgical Instrument for General Use, 21 CFR 878.4800 and Implantable Clip, 21 CFR 878.4300

### TRADE NAME:
Not established to date.

### SUMMARY STATEMENT:
The Applied Medical Clip Applier is substantially equivalent to the predicate LIGACLIP™ ERCA Clip Applier device manufactured by Ethicon. The Applied Medical Clip Applier is a sterile single use device intended for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The Applied Medical Clip Applier consists of a molded plastic clip applier handle with an actuating trigger, a 360° adjustable rotational knob on the shaft, an applicator shaft and clip applier jaws which provide secure placement of the clip to the desired vessel. The applier is sold with a pre-loaded cartridge containing 20 implantable clips. The distal tip of the shaft is a clear material which provides a color coded visual indicator for identification of the last four clips. Following release of the last clip, a lockout mechanism is activated which neutralizes the jaw actuating mechanism and prevents unanticipated cutting or pinching from the applier jaws. Functional performance and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing demonstrated the Applied Medical Clip Applier introduces no new safety and effectiveness issues when used as indicated.

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