Cleared Special

K070093 - OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K070093 · Ceremed , Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
14d
Days
Class 2
Risk

K070093 is an FDA 510(k) clearance for the OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 24, 2007 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ceremed , Inc. devices

Submission Details

510(k) Number K070093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2007
Decision Date January 24, 2007
Days to Decision 14 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 89d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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.