Cleared Traditional

KARL STORZ OR1™ SCB CONTROL (WU300) (K232406) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232406 · Karl Storz SE & CO. KG · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
54d
Days
Class 2
Risk

K232406 is an FDA 510(k) clearance for the KARL STORZ OR1™ SCB CONTROL (WU300). Classified as Endoscopic Central Control Unit (product code ODA), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on October 3, 2023 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karl Storz SE & CO. KG devices

Submission Details

510(k) Number K232406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2023
Decision Date October 03, 2023
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODA Endoscopic Central Control Unit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - ODA Endoscopic Central Control Unit

All 17
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K083598 · KARL STORZ Endoscopy-America, Inc. · May 2009
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
K080410 · KARL STORZ Endoscopy-America, Inc. · Apr 2008