Cleared Traditional

K924304 - BITE BLOCK (FDA 510(k) Clearance)

K924304 · United States Endoscopy Group, Inc. · Neurology device
Apr 1993
Decision
223d
Days
Class 2
Risk

K924304 is an FDA 510(k) clearance for the BITE BLOCK. This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).

Submitted by United States Endoscopy Group, Inc. (Waite Hill, US). The FDA issued a Cleared decision on April 6, 1993, 223 days after receiving the submission on August 26, 1992.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.

Submission Details

510(k) Number K924304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1992
Decision Date April 06, 1993
Days to Decision 223 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code JXL - Block, Bite
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.5070