Cleared Traditional

K072051 - NOVATOME, MODEL: SU101-50

K072051 is an FDA 510(k) clearance for NOVATOME, manufactured by Scholten Surgical Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K072051 · Scholten Surgical Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
69d
Days
Class 2
Risk

K072051 is an FDA 510(k) clearance for the NOVATOME, MODEL: SU101-50. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Scholten Surgical Instruments, Inc. (Lodi, US). The FDA issued a Cleared decision on October 3, 2007 after a review of 69 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 - K072051

510(k) Number K072051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2007
Decision Date October 03, 2007
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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 Peers - DWZ Device, Biopsy, Endomyocardial

All 21
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K072051.
Biopsy Forceps
K252722 · Fehling Instruments GmbH · Sep 2025
Biopsy Forceps
K170726 · Fehling Instruments GmbH & Co. KG · Jun 2017
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
K072051 · NOVATOME, MODEL: SU101-50
Download PDF FDA Summary Scholten Surgical Ins…