Cleared Traditional

K161409 - M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

K161409 is an FDA 510(k) clearance for M-Biopsy Semi-Automatic Biopsy Instrume..., manufactured by Mermaid Medical A/S. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K161409 · Mermaid Medical A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
74d
Days
Class 2
Risk

K161409 is an FDA 510(k) clearance for the M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle .... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Mermaid Medical A/S (Stenloese, DK). The FDA issued a Cleared decision on August 2, 2016 after a review of 74 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 Mermaid Medical A/S devices

FDA 510(k) Submission Details - K161409

510(k) Number K161409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2016
Decision Date August 02, 2016
Days to Decision 74 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
57d faster than avg
Panel avg: 131d · This submission: 74d
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 Consultant

Registrar Corp.
Rhonda Alexander

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNW Instrument, Biopsy

All 307
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K161409.
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
K160316 · M.D.L. S.R.L. · Oct 2016
Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
K153709 · Devicor Medical Products, Inc. · Aug 2016
CASSI II Rotational Core Biopsy System
K161234 · Scion Medical Technologies, LLC · Aug 2016
EnCor MRI Introducer Set, EnCor Probe Introducer
K161805 · Senorx, Inc. · Jul 2016
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016
Mammotome revolve Dual Vacuum Assist Biopsy System
K152989 · Devicor Medical Products, Inc. · Feb 2016