Cleared Traditional

LIGHTED FLEXGUIDE (MODIFICATION)

K953677 · Scientific Sales Intl., Inc. · Anesthesiology
Aug 1995
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K953677 is an FDA 510(k) clearance for the LIGHTED FLEXGUIDE (MODIFICATION), a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on August 25, 1995, 18 days after receiving the submission on August 7, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number K953677 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1995
Decision Date August 25, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSR — Stylet, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5790

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