Cleared Special

ClearCap Distal Attachment

K242134 · Finemedix Co., Ltd. · Gastroenterology & Urology

Aug 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K242134 is an FDA 510(k) clearance for the ClearCap Distal Attachment, a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX), submitted by Finemedix Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 20, 2024, 29 days after receiving the submission on July 22, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K242134 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2024
Decision Date	August 20, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCX — Endoscopic Irrigation/suction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.