Cleared Traditional

K912089 - MODIFIED SERIES 2100 ENDOSCOPES

K912089 is an FDA 510(k) clearance for MODIFIED SERIES 2100 ENDOSCOPES, manufactured by Medical Laser, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K912089 · Medical Laser, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
91d
Days
Class 2
Risk

K912089 is an FDA 510(k) clearance for the MODIFIED SERIES 2100 ENDOSCOPES. Classified as Mini Endoscope, Gastroenterology-urology (product code ODF), Class II - Special Controls.

Submitted by Medical Laser, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Laser, Inc. devices

FDA 510(k) Submission Details - K912089

510(k) Number K912089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date August 12, 1991
Days to Decision 91 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODF Device Classification - Class 2, Special Controls

Product Code ODF Mini Endoscope, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures In Body Cavities Of The Gi And Gu Tract. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - ODF Mini Endoscope, Gastroenterology-urology

All 8
Devices cleared under the same product code (ODF) and FDA review panel - the closest regulatory comparables to K912089.
SPYGLASS DIRECT VISULATION PROBE
K050403 · Boston Scientific Corp · Mar 2005
MINI-UB ENDOSCOPES
K941230 · Candela Laser Corp. · Jun 1994
ENDOSCOPE
K933106 · Origin Medsystems, Inc. · Oct 1993
CANDELA MINI-UB ENDOSCOPE
K910732 · Candela Laser Corp. · Apr 1991
LASERTRIPTER MINISCOPE
K874858 · Candela Laser Corp. · Feb 1988