Heat Probe Unit HPU-20, Heat Probe CD-110##/120##
FDA 510(k) K982289 · Olympus America, Inc.
510(k) numberK982289
Submission
- Device name
- Heat Probe Unit HPU-20, Heat Probe CD-110##/120##
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- June 30, 1998
- Decision date
- August 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
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Questions and answers
When was Heat Probe Unit HPU-20, Heat Probe CD-110##/120## cleared by the FDA?
Heat Probe Unit HPU-20, Heat Probe CD-110##/120## (K982289) received a 510(k) decision of Substantially Equivalent on August 19, 1998, 50 days after the submission was received.
What is the product code of K982289?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.