510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030443Substantially Equivalent

Mammary Aspiration Specimen Cytology Test

Nastech Pharmaceutical Company, Inc., Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030443 is the FDA 510(k) clearance record for MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST, a class II device, cleared for Nastech Pharmaceutical Company, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 2 510(k) clearances for Nastech Pharmaceutical Company, Inc., from to . As of , FDA records show one recall naming K030443.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nastech Pharmaceutical Company, Inc. 45 Adams Ave., Hauppauge NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260