Cleared Traditional

K080133 - MOUNTABLE ENDOSCOPIC BLADE

K080133 is an FDA 510(k) clearance for MOUNTABLE ENDOSCOPIC BLADE, manufactured by A.M. Surgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code EMF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

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

FDA 510(k) Submission Details - K080133

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.

EMF Device Classification - Class 1, General Controls

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.

Regulatory Peers - EMF Knife, Surgical

All 13
Devices cleared under the same product code (EMF) and FDA review panel - the closest regulatory comparables to K080133.
MOUNTABLE ENDOSCOPIC KNIFE
K982142 · A.M. Surgical, Inc. · Dec 1998
MICROSURGERY RAZOR BLADE HOLDER
K890214 · Kinetic Medical Products · Jan 1989
MICROSURGICAL SCARIFIER
K890215 · Kinetic Medical Products · Jan 1989
MICROSURGICAL KNIVES
K890217 · Kinetic Medical Products · Jan 1989
VAN-TEC ENDOPYELOTOMY KNIFE
K880094 · Van-Tec, Inc. · Feb 1988
VALTRAC (BAR) REMOVER DEVICE
K863752 · Davis & Geck, Inc. · Oct 1986