Pyeloscope System
by Richard Wolf Medical Instruments Corp. 510(k)
Active
510(k) K770729
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770729 | Date28 Apr 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FGA
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
A pyeloscope system is a kit nephroscope used in gastroenterology and urology procedures. It is designed for minimally invasive endoscopic examination and intervention within the urinary tract.
The device is supplied as a reusable system and requires appropriate cleaning and sterilization between uses. It is intended for use in clinical settings by trained healthcare professionals and is subject to FDA 510(k) clearance under product code FGA and regulation number 876.1500.
Other devices from Richard Wolf Medical Instruments Corp.
See all devices from Richard Wolf Medical Instruments Corp. →
Questions
AI-generated answers, 1 Oct 2026
What is the PYELOSCOPE SYSTEM used for?
The PYELOSCOPE SYSTEM is a kit nephroscope designed for minimally invasive endoscopic examination and intervention within the urinary tract, used in both gastroenterology and urology procedures by trained healthcare professionals in clinical settings.
Is the PYELOSCOPE SYSTEM reusable or single-use?
The device is supplied as a reusable system and requires appropriate cleaning and sterilization between uses to ensure safe and effective operation across multiple procedures.
How is the PYELOSCOPE SYSTEM supplied and what regulatory pathway applies?
The PYELOSCOPE SYSTEM is supplied as a complete kit for clinical use and received FDA 510(k) clearance under product code FGA and regulation number 876.1500, with a traditional clearance pathway and substantially equivalent decision.