Cleared Traditional

K832068 - CODY SACCULOTOMY TACK

K832068 is an FDA 510(k) clearance for CODY SACCULOTOMY TACK, manufactured by Micromedics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ESX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K832068 · Micromedics, Inc. · Ear, Nose, Throat device
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Oct 1983
Decision
114d
Days
Class 2
Risk

K832068 is an FDA 510(k) clearance for the CODY SACCULOTOMY TACK. Classified as Tack, Sacculotomy (cody Tack) (product code ESX), Class II - Special Controls.

Submitted by Micromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3760 - the FDA ear, nose and throat device framework. 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedics, Inc. devices

FDA 510(k) Submission Details - K832068

510(k) Number K832068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date October 19, 1983
Days to Decision 114 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 90d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ESX Device Classification - Class 2, Special Controls

Product Code ESX Tack, Sacculotomy (cody Tack)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.