Cleared Traditional

K890871 - BARD MOSS(R) GASTROSTOMY TUBE (FDA 510(k) Clearance)

Apr 1989
Decision
65d
Days
Class 2
Risk

K890871 is an FDA 510(k) clearance for the BARD MOSS(R) GASTROSTOMY TUBE. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on April 27, 1989, 65 days after receiving the submission on February 21, 1989.

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

Submission Details

510(k) Number K890871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date April 27, 1989
Days to Decision 65 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