Cleared Traditional

K832393 - ENCODYNE 4 & VACUFIX 4

K832393 · Elmed, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
118d
Days
-
Risk

K832393 is an FDA 510(k) clearance for the ENCODYNE 4 & VACUFIX 4.

Submitted by Elmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elmed, Inc. devices

FDA 510(k) Submission Details - K832393

510(k) Number K832393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date November 14, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 148d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -