Cleared Traditional

K201434 - Connected OR Hub with Voice Control

K201434 is the FDA 510(k) clearance for Connected OR Hub with Voice Control by Stryker. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K201434 · Stryker · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
57d
Days
Class 2
Risk

K201434 is an FDA 510(k) clearance for the Connected OR Hub with Voice Control, Connected OR Hub with Device Control. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on July 28, 2020 after a review of 57 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 Stryker devices

Submission Details

510(k) Number K201434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date July 28, 2020
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 692
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K201434.
FUJIFILM Video Laparoscope
K202130 · Fujifilm Corporation · Aug 2020
Disposable Laparoscope Trocar
K201641 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Aug 2020
Cyber Blade
K192499 · SIDAM S.r.l. · Jul 2020
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
K201198 · Smith & Nephew · Jul 2020
Disposable Specimen Retrieval Bag
K201243 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Jul 2020
GTK Trocars
K193272 · Guangzhou T.K Medical Instrument Co., Ltd. · Jul 2020