ENTire IRE System
FDA 510(k) K261202 · Entire Medical , Ltd.
510(k) numberK261202
Submission
- Device name
- ENTire IRE System
- Applicant
- Entire Medical , Ltd.
Herzeliya, IL - Received
- April 13, 2026
- Decision date
- May 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K251996 | ENTire IRE SystemGEI · Traditional | 01/14/2026SE |
Questions and answers
When was ENTire IRE System cleared by the FDA?
ENTire IRE System (K261202) received a 510(k) decision of Substantially Equivalent on May 29, 2026, 46 days after the submission was received.
What is the product code of K261202?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.