Cleared Traditional

K971125 - ENDO SMARTCAP (100501)

K971125 is an FDA 510(k) clearance for ENDO SMARTCAP (100501), manufactured by Endo Smart Cap Co.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K971125 · Endo Smart Cap Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
57d
Days
Class 2
Risk

K971125 is an FDA 510(k) clearance for the ENDO SMARTCAP (100501). Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Endo Smart Cap Co. (Houston, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 57 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 Endo Smart Cap Co. devices

FDA 510(k) Submission Details - K971125

510(k) Number K971125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1997
Decision Date May 23, 1997
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic 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 - OCX Endoscopic Irrigation/suction System

All 66
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K971125.
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K953655 · Johnson & Johnson Medical, Inc. · Oct 1995
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