Cleared Traditional

K983566 - 3-CHIP VIDEO CAMERA

K983566 is the FDA 510(k) clearance for 3-CHIP VIDEO CAMERA by Stryker Endoscopy. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983566 · Stryker Endoscopy · General & Plastic Surgery device
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Jan 1999
Decision
90d
Days
Class 2
Risk

K983566 is an FDA 510(k) clearance for the 3-CHIP VIDEO CAMERA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on January 11, 1999 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

Submission Details

510(k) Number K983566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 11, 1999
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.

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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K983566.
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K990028 · Ethicon Endo-Surgery, Inc. · Apr 1999
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
K990188 · Intuitive Surgical, Inc. · Apr 1999
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
K990379 · Dexide, Inc. · Mar 1999
DCI ENDOSCOPE
K983363 · KARL STORZ Endoscopy-America, Inc. · Dec 1998
AUTO SUTURE LAPAROSCOPES DEVICE
K983293 · United States Surgical, A Division of Tyco Healthc · Dec 1998
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
K983279 · Richard Wolf Medical Instruments Corp. · Dec 1998