Cleared Traditional

K973788 - MICROVASIVE LIPTHOTRIPSY PROBES

K973788 is the FDA 510(k) clearance for MICROVASIVE LIPTHOTRIPSY PROBES by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FFK) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K973788 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
107d
Days
Class 2
Risk

K973788 is an FDA 510(k) clearance for the MICROVASIVE LIPTHOTRIPSY PROBES. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on January 21, 1998 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K973788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date January 21, 1998
Days to Decision 107 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
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 - FFK Lithotriptor, Electro-hydraulic

All 26
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K973788.
KSEA CALCUSPLIT
K992114 · Karl Storz Endoscopy · Aug 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · Northgate Technologies, Inc. · Jul 1999
KSEA CALCUSPLIT
K981233 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
PULSE GUARD 3FR ELECTRODE
K944571 · Northgate Technologies, Inc. · Mar 1995
RIWOLITH 2280 PROBES
K931755 · Richard Wolf Medical Instruments Corp. · Apr 1994
PULSE GUARD ELECTRODE
K925396 · Northgate Technologies, Inc. · Jul 1993