Cleared Traditional

K031758 - ACMI M4 TELESCOPES

K031758 is an FDA 510(k) clearance for ACMI M4 TELESCOPES, manufactured by Acmi Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FBP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K031758 · Acmi Corporation · Gastroenterology & Urology device
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Sep 2003
Decision
88d
Days
Class 2
Risk

K031758 is an FDA 510(k) clearance for the ACMI M4 TELESCOPES. Classified as Telescope, Rigid, Endoscopic (product code FBP), Class II - Special Controls.

Submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on September 2, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Acmi Corporation devices

FDA 510(k) Submission Details - K031758

510(k) Number K031758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2003
Decision Date September 02, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBP Device Classification - Class 2, Special Controls

Product Code FBP Telescope, Rigid, Endoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FBP Telescope, Rigid, Endoscopic

Devices cleared under the same product code (FBP) and FDA review panel - the closest regulatory comparables to K031758.
OES ELITE Telescopes, Protective Tube
K151191 · Olympus Winter & Ibe GmbH · Nov 2015
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
K984607 · Richard Wolf Medical Instruments Corp. · Mar 1999
TELESCOPE, RIGID ENDOSCOPE
K760177 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976