Cleared Special

OptaBlate Radiofrequency (RF) Generator System

K250327 · Stryker Instruments · General & Plastic Surgery

Apr 2025

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K250327 is an FDA 510(k) clearance for the OptaBlate Radiofrequency (RF) Generator System, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on April 15, 2025, 69 days after receiving the submission on February 5, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K250327 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2025
Decision Date	April 15, 2025
Days to Decision	69 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
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).