Cleared Traditional

K963571 - VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR

K963571 is an FDA 510(k) clearance for VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR, manufactured by Vygon Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K963571 · Vygon Corp. · General Hospital
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Jun 1997
Decision
270d
Days
Class 2
Risk

K963571 is an FDA 510(k) clearance for the VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Vygon Corp. (West Cadwell, US). The FDA issued a Cleared decision on June 2, 1997 after a review of 270 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Vygon Corp. devices

FDA 510(k) Submission Details - K963571

510(k) Number K963571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date June 02, 1997
Days to Decision 270 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 129d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K963571.
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SHARPS SHUTTLE
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K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
LIFESHIELD BLUNT CANNULA
K963351 · Abbott Laboratories · Feb 1997