510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884900Substantially Equivalent

Siemens Sector 3.5 and 5.0 Mhz Cda Transducer

Siemens Medical Solutions USA, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884900 is the FDA 510(k) clearance record for SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K884900.

Clearance record

Decision date
Received
(51 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Siemens Medical Solutions USA, Inc. 5675 Gibraltar Dr., Pleasanton CA
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