Cleared Traditional

K885005 - MICROVASIVE GOLD PROBE

K885005 is an FDA 510(k) clearance for MICROVASIVE GOLD PROBE, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K885005 · Boston Scientific Corp · Gastroenterology & Urology device
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Feb 1989
Decision
62d
Days
Class 2
Risk

K885005 is an FDA 510(k) clearance for the MICROVASIVE GOLD PROBE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on February 1, 1989 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K885005

510(k) Number K885005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1988
Decision Date February 01, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 131d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K885005.
WILTEK PAPILLOTOME
K894861 · Wiltek Medical, Inc. · Dec 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895 · Everest Medical Corp. · Sep 1989
CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200
K884025 · Circon Acmi · Mar 1989
CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
K884254 · Circon Acmi · Jan 1989
CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
K884252 · Circon Acmi · Jan 1989
BICAP ABLATING FORCEPS BAF-7
K884306 · Circon Acmi · Jan 1989
K885005 · MICROVASIVE GOLD PROBE
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