Cleared Traditional

K884275 - FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT (FDA 510(k) Clearance)

K884275 · Abbott Laboratories · Gastroenterology & Urology device
Dec 1988
Decision
71d
Days
Class 2
Risk

K884275 is an FDA 510(k) clearance for the FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT. 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 December 22, 1988, 71 days after receiving the submission on October 12, 1988.

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

Submission Details

510(k) Number K884275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 12, 1988
Decision Date December 22, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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