Operating Laparoscope, 10-5 Mm, Angeled, Operating Laparoscope 12-7mm, Angled, Operating Laparoscope, 10-5, ,. Oblique, D
by Richard Wolf Medical Instruments Corp. 510(k)
Active
510(k) K991718
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991718 | Date12 Aug 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
An operating laparoscope is a rigid endoscopic instrument used for viewing the interior of the patient through surgically produced accesses for examination, diagnosis, and/or therapy in connection with endoscopic accessories for laparoscopy. This device is designed for use in general and plastic surgery procedures.
It is supplied as a reusable instrument and is classified under FDA product code GCJ as a Class II device with special controls. The device received FDA 510(k) clearance (K991718) on August 12, 1999, and is intended for use in endoscopic laparoscopic procedures.
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Questions
AI-generated answers, 6 Oct 2026
What is the operating laparoscope used for?
It is used for viewing the interior of the patient through surgically created accesses to enable examination, diagnosis, and/or therapy during endoscopic laparoscopic procedures, particularly in general and plastic surgery.
Is the laparoscope reusable or single-use?
The device is supplied as a reusable instrument, meaning it is designed for multiple uses after proper cleaning and sterilization between procedures.
What are the key specifications of this laparoscope model?
This model features a 10-5mm diameter with an angled oblique view direction, designed as a rigid endoscopic instrument for use with laparoscopic accessories in minimally invasive surgery.
How was this device cleared for market?
The device received FDA 510(k) clearance under K991718 on August 12, 1999, as substantially equivalent to a predicate device, and is classified as a Class II device under product code GCJ with special controls.