Cleared Traditional

MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES (K884097) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884097 · Circon Acmi · Gastroenterology & Urology device
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Apr 1989
Decision
201d
Days
Class 2
Risk

K884097 is an FDA 510(k) clearance for the MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Circon Acmi (Stamford, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 201 days - an extended review 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: 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 Circon Acmi devices

Submission Details

510(k) Number K884097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date April 17, 1989
Days to Decision 201 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 130d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K884097.
CONCENTRIC BALLOON GOOGLE
K112698 · United States Endoscopy Group, Inc. · May 2012
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
K073484 · Ethicon Endo-Surgery, Inc. · Mar 2008
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp · Mar 2001