Cleared Traditional

K082750 - ENTACT SEPTAL STAPLER, MODEL 610-00100 (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082750 · Entrigue Surgical, Inc. · Ear, Nose, Throat device
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Jan 2009
Decision
109d
Days
Class 2
Risk

K082750 is an FDA 510(k) clearance for the ENTACT SEPTAL STAPLER, MODEL 610-00100. Classified as Septal Stapler/absorbable Staples (product code OLL), Class II - Special Controls.

Submitted by Entrigue Surgical, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 6, 2009 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 878.4750 - 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 Entrigue Surgical, Inc. devices

Submission Details

510(k) Number K082750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2008
Decision Date January 06, 2009
Days to Decision 109 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 89d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLL Septal Stapler/absorbable Staples
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
Definition To Approximate Soft Tissues By Means Of Absorbable Staples Delivered Via A Pre-loaded Stapler Delivery System For Use During Nasal Septal Surgery, With Or Without Cartilage Reinserted. To Connect Internal Nasal Tissues To Aid Healing During Nasal Septum Reconstruction.
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.