Cleared Special

K261202 - ENTire IRE System

K261202 is the FDA 510(k) clearance for ENTire IRE System by Entire Medical , Ltd.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 46-day FDA review.

K261202 · Entire Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
46d
Days
Class 2
Risk

K261202 is an FDA 510(k) clearance for the ENTire IRE System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Entire Medical , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on May 29, 2026 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Entire Medical , Ltd. devices

Submission Details

510(k) Number K261202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2026
Decision Date May 29, 2026
Days to Decision 46 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
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: 115d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

MCRA, LLC
Glenn Stiegman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K261202.
OsteoCool™ RF Ablation System
K253656 · Medtronic Sofamor Danek USA, Inc. · Jun 2026
MILAN System
K253803 · Lumenis Be, Ltd. · Jun 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · F Care Systems USA, LLC · Jun 2026
VIVA combo RF System
K252833 · Starmed Co., Ltd. · May 2026
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
K253134 · Lagis Enterprise Co., Ltd. · May 2026
RhinAer+ Stylus
K260522 · Aerin Medical, Inc. · May 2026