Cleared Special

K103805 - MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR...

K103805 is the FDA 510(k) clearance for MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR... by Medical Wire & Equipment Company (Bath), Ltd.. It is a Class 1 Microbiology device (product code LIO) cleared through the Special 510(k) pathway after a 28-day FDA review.

K103805 · Medical Wire & Equipment Company (Bath), Ltd. · Microbiology device
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Jan 2011
Decision
28d
Days
Class 1
Risk

K103805 is an FDA 510(k) clearance for the MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTI.... Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, Wiltshire, GB). The FDA issued a Cleared decision on January 25, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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 Medical Wire & Equipment Company (Bath), Ltd. devices

Submission Details

510(k) Number K103805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2010
Decision Date January 25, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIO Device, Specimen Collection

All 17
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