Cleared Special

K990379 - MODIFICATION TO MULTAPORT CANNULA

K990379 is the FDA 510(k) clearance for MODIFICATION TO MULTAPORT CANNULA by Dexide, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Special 510(k) pathway after a 24-day FDA review.

K990379 · Dexide, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
24d
Days
Class 2
Risk

K990379 is an FDA 510(k) clearance for the MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Dexide, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 24 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 Dexide, Inc. devices

Submission Details

510(k) Number K990379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date March 04, 1999
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 693
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K990379.
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · Smith & Nephew, Inc. · Apr 1999
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
3-CHIP VIDEO CAMERA
K983566 · Stryker Endoscopy · Jan 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