K961762 · United States Endoscopy Group, Inc. · KNS · Jul 22, 1996 · Gastroenterology, Urology
Device Facts
Record ID
K961762
Device Name
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
Applicant
United States Endoscopy Group, Inc.
Product Code
KNS · Gastroenterology, Urology
Decision Date
Jul 22, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.4300
Device Class
Class 2
Indications for Use
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
Device Story
Reusable handle for endoscopic accessories; interfaces with biopsy forceps and polypectomy snares. Used in clinical endoscopic settings by physicians. Device facilitates mechanical manipulation of accessories during procedures. Benefits include reusability for endoscopic interventions.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Reusable endoscopic handle; materials certified to appropriate standards; quality assurance per MIL-STD-9858.
Indications for Use
Indicated for use with endoscopic accessories (biopsy forceps, polypectomy snares) during endoscopic procedures. Contraindicated for patients where endoscopic procedures are contraindicated. Physician determines patient appropriateness.
Regulatory Classification
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Submission Summary (Full Text)
{0}
JUL 22 1996
K961762
# SECTION II
## SAFETY AND EFFECTIVENESS
### U.S.E. REUSABLE HANDLE SUMMARY
The Summary of Safety and Effectiveness on the Reusable Endoscopic Accessory Handle used reflects data available and present at the time the summary was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alteration for the conclusions or recommendations set forth.
## Procedure/Product Overview
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
## Contraindications
The Reusable handle is contraindicated for use in any contraindication to performing any type of endoscopic procedure.
The physician will determine patient’s appropriateness for the procedure.
## Manufacturing Overview
U.S.E. designs, manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices.
U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.
Materials used in the manufacturing process are certified to standards appropriate for their use.
## Bibliography
Drossman, D.A. (Editor). *Manual of Gastroenterologic Procedures* (2nd Edition), New York: Raven Press, 1987.
Society of Gastroenterology Nurses & Associates, Inc. *Manual of Gastrointestinal Procedures*. (2nd Edition). Rochester: SGNA, 1989.
Waye, Jerome D. "The Management of Colonoscopy Complications." *Gastroenterology & Endoscopy*, May 1993, pp 23.
Waye, J., Geenan, J., Fleischer, D. and Venue, R. *Techniques in Therapeutic Endoscopy*, New York: Gowen Medical Publishing, Ltd., 1987.
