Cleared Traditional

K010489 - DYONICS VISION 111 MOBILE VIDEO UNIT

K010489 is an FDA 510(k) clearance for DYONICS VISION 111 MOBILE VIDEO UNIT, manufactured by Smith & 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 49-day FDA review.

K010489 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
49d
Days
Class 2
Risk

K010489 is an FDA 510(k) clearance for the DYONICS VISION 111 MOBILE VIDEO UNIT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on April 10, 2001 after a review of 49 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.

FDA 510(k) Submission Details - K010489

510(k) Number K010489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date April 10, 2001
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K010489.
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · KARL STORZ Endoscopy-America, Inc. · May 2001
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
K010789 · A & A Medical, Inc. · Apr 2001
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
K011016 · Lsi Solutions · Apr 2001
XTRACTOR, MODEL M143
K010220 · Instruments Medicaux G.B., Inc. · Apr 2001
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
K010569 · Karl Storz Endoscopy · Apr 2001
GENERAL SURGICAL LAPAROSCOPES
K003803 · Global Endoscopy, Inc. · Mar 2001
K010489 · DYONICS VISION 111 MOBILE VIDEO UNIT
Download PDF FDA Summary Smith & Nephew, Inc.