Cleared Traditional

K012088 - NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT

K012088 is an FDA 510(k) clearance for NASTECH MAMMARY ASPIRATION SPECIMAN CYT..., 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 168-day FDA review.

K012088 · Nastech Pharmaceutical Company, Inc. · Gastroenterology & Urology device
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Dec 2001
Decision
168d
Days
Class 2
Risk

K012088 is an FDA 510(k) clearance for the NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT. 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 December 18, 2001 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nastech Pharmaceutical Company, Inc. devices

FDA 510(k) Submission Details - K012088

510(k) Number K012088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2001
Decision Date December 18, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 131d · This submission: 168d
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 324
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K012088.
BIOSUC
K013108 · Hakko Medical Co., Ltd. · Apr 2002
CARIS MINITOME BIOPSY INSTRUMENT
K020024 · Artemis Medical, Inc. · Apr 2002
TRAPSYSTEM SET
K013692 · H.S. Hospital Service S.R.L. · Feb 2002
ANCHOR GUIDE LESION LOCALIZATION DEVICE
K012023 · Senorx, Inc. · Sep 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · Ranfac, Corp. · Aug 2001
SPEEDYBELL
K010735 · Biopsybell S.A.S. · Aug 2001