Cleared Traditional

FiAPC plus probes

K242044 · Erbe Elektromedizin GmbH · General & Plastic Surgery

Aug 2024

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K242044 is an FDA 510(k) clearance for the FiAPC plus probes, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on August 26, 2024, 45 days after receiving the submission on July 12, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K242044 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2024
Decision Date	August 26, 2024
Days to Decision	45 days
Submission Type	Traditional
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).