Cleared Traditional

K991670 - SILVERSTEIN MICROWICK

K991670 is an FDA 510(k) clearance for SILVERSTEIN MICROWICK, manufactured by Micromedics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K991670 · Micromedics, Inc. · Ear, Nose, Throat device
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Aug 1999
Decision
101d
Days
Class 2
Risk

K991670 is an FDA 510(k) clearance for the SILVERSTEIN MICROWICK. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on August 26, 1999 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 - K991670

510(k) Number K991670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date August 26, 1999
Days to Decision 101 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 90d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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.

Regulatory Peers - ETD Tube, Tympanostomy

All 84
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K991670.
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · Gyrus Ent LLC · Jun 2000
FLUOROPLASTIC VENTILATION TUBES
K992222 · Gyrus Ent LLC · Aug 1999
EXMOOR MYRINGOTOMY KIT
K980828 · Exmoor Plastics , Ltd. · Oct 1998
TYMPANOSTOMY TUBE
K981575 · Grace Medical, Inc. · Jul 1998