Cleared Traditional

K913786 - FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP (FDA 510(k) Clearance)

K913786 · Abbott Laboratories · Gastroenterology & Urology device
Nov 1991
Decision
74d
Days
Class 2
Risk

K913786 is an FDA 510(k) clearance for the FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).

Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on November 5, 1991, 74 days after receiving the submission on August 23, 1991.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K913786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 23, 1991
Decision Date November 05, 1991
Days to Decision 74 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5980