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

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Heat Probe Unit Hpu-20, Heat Probe Cd-110##/120##.

Pre-market Notification Details

• Device ID: K982289
• 510k Number: K982289
• Device Name: HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
• Classification: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Applicant: OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157
• Contact: Laura Storms-tyler
• Correspondent: Laura Storms-tyler; OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157
• Product Code: KNS
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-06-30
• Decision Date: 1998-08-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14953170037655	K982289	000
14953170037624	K982289	000
04953170025884	K982289	000
04953170022791	K982289	000
04953170022784	K982289	000