Cleared Traditional

CIRCON ACMI BICAP III THERAPEUTIC SYSTEM (K884254) - FDA 510(k) Clearance

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

K884254 · Circon Acmi · Gastroenterology & Urology device
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Jan 1989
Decision
92d
Days
Class 2
Risk

K884254 is an FDA 510(k) clearance for the CIRCON ACMI BICAP III THERAPEUTIC SYSTEM. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Circon Acmi (Stamford, US). The FDA issued a Cleared decision on January 11, 1989 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 K884254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date January 11, 1989
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 92
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K884254.
RESECTOSCOPE LOOPS
K903323 · Olympus Corp. · Oct 1990
ZIMMON PAPILLOTOME
K901443 · Wilson-Cook Medical, Inc. · Jun 1990
MICROVASIVE GOLD PROBE
K885005 · Boston Scientific Corp · Feb 1989
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · Cook Urological, Inc. · Aug 1988
ROTATABLE POLYPECTOMY SNARE POS-1
K851958 · Wilson-Cook Medical, Inc. · Jul 1985
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE
K851964 · Wilson-Cook Medical, Inc. · Jun 1985