APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
Device Facts
| Record ID | K971498 |
|---|---|
| Device Name | APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE |
| Applicant | Applied Medical Resources |
| Product Code | EZB · Gastroenterology, Urology |
| Decision Date | May 5, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 1 |
Indications for Use
The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.
Device Story
Device: Applied Medical Laparoscopic Guidewire; radiopaque body with flexible, tapered tip. Function: assists physician in navigation, placement, and exchange of laparoscopic and general surgical instrumentation. Usage: clinical setting; operated by physicians. Benefit: facilitates access and visibility during surgical procedures.
Clinical Evidence
Bench testing only. Mechanical and biocompatibility tests performed to verify functional/structural integrity and material safety.
Technological Characteristics
Radiopaque body; flexible, tapered tip. Materials comparable to predicate devices. Dimensions include various lengths.
Indications for Use
Indicated for use by physicians to assist in the navigation, placement, and exchange of laparoscopic and general surgical instrumentation.
Regulatory Classification
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Predicate Devices
Related Devices
- K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO · Flexmedics · Mar 15, 1999
- K960866 — LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. · Lake Region Mfg., Inc. · Apr 5, 1996
- K972582 — URESIL GUIDEWIRE · Uresil Corp. · Nov 21, 1997
- K042264 — GUIDEWIRES · Rocket Medical Plc · Nov 24, 2004
- K993688 — AED LAPAROSCOPE · National Advanced Endoscopy Devices, Inc. · Dec 6, 1999
