Cleared Traditional

PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX

K984607 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology
Mar 1999
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K984607 is an FDA 510(k) clearance for the PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX, a Telescope, Rigid, Endoscopic (Class II — Special Controls, product code FBP), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 5, 1999, 67 days after receiving the submission on December 28, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K984607 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1998
Decision Date March 05, 1999
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FBP — Telescope, Rigid, Endoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500