Cleared Traditional

K030443 - MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

K030443 is an FDA 510(k) clearance for MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST, manufactured by Nastech Pharmaceutical Company, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K030443 · Nastech Pharmaceutical Company, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
87d
Days
Class 2
Risk

K030443 is an FDA 510(k) clearance for the MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Nastech Pharmaceutical Company, Inc. (Hauppauge, US). The FDA issued a Cleared decision on May 9, 2003 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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.

View all Nastech Pharmaceutical Company, Inc. devices

FDA 510(k) Submission Details - K030443

510(k) Number K030443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date May 09, 2003
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K030443.
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