Cleared Traditional

K241022 - Sterile single use tip cleaner (WK800-S10 , WK800-S20)
(FDA 510(k) Clearance)

K241022 · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · General & Plastic Surgery

Jul 2024

Decision

87d

Days

Class 2

Risk

K241022 is an FDA 510(k) clearance for the Sterile single use tip cleaner (WK800-S10 , WK800-S20). This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI).

Submitted by Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd (Huizhou, CN). The FDA issued a Cleared decision on July 11, 2024, 87 days after receiving the submission on April 15, 2024.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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)..

Submission Details

510(k) Number	K241022 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2024
Decision Date	July 11, 2024
Days to Decision	87 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).