Product code FDC— Gastroenterology, Urology
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
- Classification name
- Resectoscope, Working Element
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code FDC
FDA has cleared devices under product code FDC between 1976 and 2002, filed by 7 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
- 2002
- 1999
- 1995
- 1994
- 1989
- 1984
- 1976
Top applicants under product code FDC
Recent clearances under product code FDC
- K021166 — ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
- K992141 — OLYMPUS WORKING ELEMENT FOR PROBES
- K991426 — MAHE INSTRUMENTS
- K942626 — CONTINUOUS FLOW BIOPSY PROBE
- K933962 — GM CONTINUOUS FLOW BIOPSY PROBE
- K895643 — MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
- K894363 — UROPUMP* FLUID MANAGEMENT SYSTEM
- K842997 — LASER RECTOSCOPE SET 784
- K760182 — SHEATH, RESECTOSCOPE
- K760184 — ELEMENT, WORKING
- K760174 — ADAPTER, RESECTOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.