Cleared Traditional

K884900 - SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRAN...

K884900 is the FDA 510(k) clearance for SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRAN... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K884900 · Siemens Medical Solutions USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
51d
Days
Class 2
Risk

K884900 is an FDA 510(k) clearance for the SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 51 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K884900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1988
Decision Date January 13, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 161
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K884900.
MAXX 470 CORE BIOPSY GUN
K900082 · Dlp, Inc. · Jun 1990
GASTRO ENTEROLOGICAL BIOPTOME
K894419 · Symbiosis Corp. · Sep 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · Boston Scientific Corp · Feb 1989
BARD(R) ASPIRATION BIOPSY SYSTEM
K883469 · C.R. Bard, Inc. · Jan 1989
BARD BIOPSY NEEDLE GUIDANCE DEVICE
K883374 · C.R. Bard, Inc. · Sep 1988
VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP
K880096 · Van-Tec, Inc. · Mar 1988