Cleared Special

K232157 - Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232157 · Stryker Corporation · General & Plastic Surgery device

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Aug 2023

Decision

29d

Days

Class 2

Risk

K232157 is an FDA 510(k) clearance for the Connected OR Hub with Device and Voice Control, SDC4K Information Management .... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Stryker Corporation (San Jose, US). The FDA issued a Cleared decision on August 18, 2023 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Corporation devices

Submission Details

510(k) Number	K232157 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 20, 2023
Decision Date	August 18, 2023
Days to Decision	29 days
Submission Type	Special
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

85d faster than avg

Panel avg: 114d · This submission: 29d

Pathway characteristics

Modification to existing cleared device.

Device Classification

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.