Cleared Traditional

KARL STORZ Holders

K240506 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery
Oct 2024
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K240506 is an FDA 510(k) clearance for the KARL STORZ Holders, a Endoscope Holder (Class II — Special Controls, product code OCV), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 22, 2024, 244 days after receiving the submission on February 21, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K240506 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2024
Decision Date October 22, 2024
Days to Decision 244 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OCV — Endoscope Holder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.

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