Cleared Traditional

K070596 - TOPICAL APPLICATOR

K070596 is an FDA 510(k) clearance for TOPICAL APPLICATOR, manufactured by Sharn, Inc.. The device is a Class 2 Anesthesiology device with product code CCT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K070596 · Sharn, Inc. · Anesthesiology device
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Jun 2007
Decision
111d
Days
Class 2
Risk

K070596 is an FDA 510(k) clearance for the TOPICAL APPLICATOR. Classified as Applicator (laryngo-tracheal), Topical Anesthesia (product code CCT), Class II - Special Controls.

Submitted by Sharn, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 21, 2007 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5170 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sharn, Inc. devices

FDA 510(k) Submission Details - K070596

510(k) Number K070596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2007
Decision Date June 21, 2007
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 140d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCT Device Classification - Class 2, Special Controls

Product Code CCT Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5170
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCT Applicator (laryngo-tracheal), Topical Anesthesia

Devices cleared under the same product code (CCT) and FDA review panel - the closest regulatory comparables to K070596.
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