Product code FGA— Gastroenterology, Urology
ACMI RIGI-FLEX NEPHORSCOPE
- Classification name
- Kit, Nephroscope
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code FGA
FDA has cleared devices under product code FGA between 1977 and 2024, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2016
- 2007
- 2000
- 1995
- 1994
- 1993
- 1985
- 1979
- 1977
Top applicants under product code FGA
Adverse events under product code FGA
product code FGA- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FGA
- K232370 — Percutaneous Nephroscope System
- K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
- K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
- K994223 — NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW
- K950433 — KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
- K940594 — KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
- K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE
- K853486 — OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
- K791182 — ACMI RIGI-FLEX NEPHORSCOPE
- K770729 — PYELOSCOPE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.