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
Indications for 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)
{0}
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
(714) 582-6120 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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