Cleared Traditional

K970053 - ULTRATOMERX

K970053 is the FDA 510(k) clearance for ULTRATOMERX by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K970053 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
80d
Days
Class 2
Risk

K970053 is an FDA 510(k) clearance for the ULTRATOMERX. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Boston Scientific Corp devices

Submission Details

510(k) Number K970053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1997
Decision Date March 28, 1997
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 114
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K970053.
WILSON-COOK NEEDLE KNIFE PAPILLOTOME
K972674 · Wilson-Cook Medical, Inc. · Aug 1997
ANGLED TIP POLYPECTOMY SNARE
K970945 · United States Endoscopy Group, Inc. · May 1997
MICROVASIVE GOLD PROBE
K970278 · Boston Scientific Corp · Apr 1997
KARL STORZ REMORGIDA FORCEPS
K962083 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
PAPILLOTOME
K962346 · United States Endoscopy Group, Inc. · Aug 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762 · United States Endoscopy Group, Inc. · Jul 1996