Cleared Traditional

K223116 - 8X-10-6XXX Camera Head

K223116 is an FDA 510(k) clearance for 8X-10-6XXX Camera Head, manufactured by Santa Barbara Imaging Systems. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K223116 · Santa Barbara Imaging Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
148d
Days
Class 2
Risk

K223116 is an FDA 510(k) clearance for the 8X-10-6XXX Camera Head. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Santa Barbara Imaging Systems (Goleta, US). The FDA issued a Cleared decision on February 28, 2023 after a review of 148 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 Santa Barbara Imaging Systems devices

FDA 510(k) Submission Details - K223116

510(k) Number K223116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date February 28, 2023
Days to Decision 148 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 115d · This submission: 148d
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 803
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K223116.
HOPKINS Telescopes
K223923 · KARL STORZ Endoscopy-America, Inc. · Mar 2023
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
K223593 · Taiwan Surgical Corporation · Mar 2023
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
K222828 · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · Mar 2023
Arthrex SynergyID Endoscopic Imaging System
K223759 · Arthex, Inc. · Feb 2023
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
K221591 · Schoelly Fiberoptic GmbH · Feb 2023
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
K230216 · Stryker · Feb 2023