Cleared Traditional

MOUNTABLE ENDOSCOPIC BLADE (K080133) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K080133 · A.M. Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
55d
Days
Class 1
Risk

K080133 is an FDA 510(k) clearance for the MOUNTABLE ENDOSCOPIC BLADE. Classified as Knife, Surgical (product code EMF), Class I - General Controls.

Submitted by A.M. Surgical, Inc. (Smithtown, US). The FDA issued a Cleared decision on March 13, 2008 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A.M. Surgical, Inc. devices

Submission Details

510(k) Number K080133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2008
Decision Date March 13, 2008
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMF Knife, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.