Cleared Traditional

K241401 - Connected OR Hub with Device and Voice Control

Also marketed or referenced as:
SDC4K Information Management System with Device and Voice Control

K241401 is an FDA 510(k) clearance for Connected OR Hub with Device and Voice ..., manufactured by Stryker Endoscopy. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K241401 · Stryker Endoscopy · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
90d
Days
Class 2
Risk

K241401 is an FDA 510(k) clearance for the Connected OR Hub with Device and Voice Control. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 15, 2024 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Endoscopy devices

FDA 510(k) Submission Details - K241401

510(k) Number K241401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2024
Decision Date August 15, 2024
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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).
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 - GCJ Laparoscope, General & Plastic Surgery

All 1065
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K241401.
Bladeless Trocar
K241052 · Advamedix, GmbH · Oct 2024
TroCare TroKit Laparoscope Lens Wiper (CP000626)
K241796 · TroCare, LLC · Oct 2024
da Vinci Handheld Camera
K241913 · Intuitive Surgical Operations, Inc. · Aug 2024
Medical Monitor (32HR734S)
K241402 · Lg Electronics.Inc · Aug 2024
Stellar Imaging System
K241530 · Guangdong Optomedic Technologies, Inc. · Aug 2024
Universal Seal (5-12 mm)
K241360 · Intuitive Surgical, Inc. · Aug 2024