Cleared Traditional

K982289 - HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##

K982289 is an FDA 510(k) clearance for HEAT PROBE UNIT HPU-20, manufactured by Olympus America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K982289 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
50d
Days
Class 2
Risk

K982289 is an FDA 510(k) clearance for the HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on August 19, 1998 after a review of 50 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.

View all Olympus America, Inc. devices

FDA 510(k) Submission Details - K982289

510(k) Number K982289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1998
Decision Date August 19, 1998
Days to Decision 50 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
81d faster than avg
Panel avg: 131d · This submission: 50d
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 155
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K982289.
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855 · CooperSurgical, Inc. · Mar 1999
WILSON-COOK BIPOLAR PROBE
K990145 · Wilson-Cook Medical, Inc. · Mar 1999
BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
K982557 · Bard Interventional Products Div. · Sep 1998
COOPERSURGICAL INFRARED COAGULATOR
K974168 · Hogan & Hartson · Jan 1998
SPHINCTEROTOME
K973826 · Boston Scientific Corp · Dec 1997
COBRA HAND PIECE
K973366 · Vidamed, Inc. · Nov 1997