Cleared Traditional

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

K252043 · Olympus Winter & Ibe GmbH · Ear, Nose, Throat

Sep 2025

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K252043 is an FDA 510(k) clearance for the Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 23, 2025, 85 days after receiving the submission on June 30, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K252043 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	September 23, 2025
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — 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).