Cleared Traditional

ASPISAFE GASTRIC TUBE

K961711 · B.Braun Medical, Inc. · Gastroenterology & Urology
Jun 1997
Decision
405d
Days
Class 2
Risk

About This 510(k) Submission

K961711 is an FDA 510(k) clearance for the ASPISAFE GASTRIC TUBE, a Tube, Nasogastric (Class II — Special Controls, product code BSS), submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 11, 1997, 405 days after receiving the submission on May 2, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K961711 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1996
Decision Date June 11, 1997
Days to Decision 405 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code BSS — Tube, Nasogastric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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