Cleared Traditional

K221740 - SMITH & NEPHEW INTELLIO 4K CAMERA CONTR...

K221740 is an FDA 510(k) clearance for SMITH & NEPHEW INTELLIO 4K CAMERA CONTR..., manufactured by Smith and Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K221740 · Smith and Nephew, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
127d
Days
Class 2
Risk

K221740 is an FDA 510(k) clearance for the SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), S.... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Smith and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 20, 2022 after a review of 127 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 Smith and Nephew, Inc. devices

FDA 510(k) Submission Details - K221740

510(k) Number K221740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2022
Decision Date October 20, 2022
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
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 787
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