Product code FBP— Gastroenterology, Urology
ACMI M4 TELESCOPES
- Classification name
- Telescope, Rigid, Endoscopic
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 5
- First cleared
- Most recent
Market context for product code FBP
FDA has cleared devices under product code FBP between 1976 and 2015, filed by 5 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
- 2015
- 2012
- 2003
- 1999
- 1976
Top applicants under product code FBP
Recent clearances under product code FBP
- K151191 — OES ELITE Telescopes, Protective Tube
- K113062 — ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
- K031758 — ACMI M4 TELESCOPES
- K984607 — PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
- K760177 — TELESCOPE, RIGID ENDOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.