Cleared Traditional

K170726 - Biopsy Forceps

K170726 is an FDA 510(k) clearance for Biopsy Forceps, manufactured by Fehling Instruments GmbH & Co. KG. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K170726 · Fehling Instruments GmbH & Co. KG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
85d
Days
Class 2
Risk

K170726 is an FDA 510(k) clearance for the Biopsy Forceps. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Fehling Instruments GmbH & Co. KG (Karlstein, DE). The FDA issued a Cleared decision on June 2, 2017 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4075 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K170726

510(k) Number K170726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2017
Decision Date June 02, 2017
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWZ Device Classification - Class 2, Special Controls

Product Code DWZ Device, Biopsy, Endomyocardial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4075
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Visamed GmbH
Arne Briest

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 - DWZ Device, Biopsy, Endomyocardial

All 17
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K170726.
Biopsy Forceps
K252722 · Fehling Instruments GmbH · Sep 2025
NOVATOME, MODEL: SU101-50
K072051 · Scholten Surgical Instruments, Inc. · Oct 2007
SPARROWHAWK DISPOSABLE
K010473 · Atc Technologies, Inc. · Jun 2001
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · Boston Scientific Corp · Feb 2000
ULTRA-CBX
K991486 · Medcanica, Inc. · Nov 1999
T-REX BIOPSY FORCEPS
K973818 · Boston Scientific Corp · Dec 1997