Cleared Traditional

K971584 - CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)

K971584 is an FDA 510(k) clearance for CLARUS MODEL 2127-900 SERIES ENDOSCOPE ..., manufactured by Clarus Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCV cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K971584 · Clarus Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
23d
Days
Class 2
Risk

K971584 is an FDA 510(k) clearance for the CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES). Classified as Endoscope Holder (product code OCV), Class II - Special Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 23 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 Clarus Medical Systems, Inc. devices

FDA 510(k) Submission Details - K971584

510(k) Number K971584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1997
Decision Date May 23, 1997
Days to Decision 23 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 131d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCV Device Classification - Class 2, Special Controls

Product Code OCV Endoscope Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.
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 - OCV Endoscope Holder

All 8
Devices cleared under the same product code (OCV) and FDA review panel - the closest regulatory comparables to K971584.
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
K093616 · Carefusion 2200 · Dec 2009
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
K992006 · Integra Neurocare, LLC · Aug 1999
KSEA ENDOSCOPE HOLDER
K990334 · KARL STORZ Endoscopy-America, Inc. · Mar 1999
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · Olympus America, Inc. · May 1997