Cleared Traditional

K930022 - SPHINCTEROTOME

K930022 is the FDA 510(k) clearance for SPHINCTEROTOME by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K930022 · Boston Scientific Corp · Gastroenterology & Urology device
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Apr 1993
Decision
112d
Days
Class 2
Risk

K930022 is an FDA 510(k) clearance for the SPHINCTEROTOME. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on April 27, 1993 after a review of 112 days - within the typical 510(k) review window.

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: 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 K930022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date April 27, 1993
Days to Decision 112 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDI Snare, Flexible
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 - FDI Snare, Flexible

All 40
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K930022.
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
K941750 · Boston Scientific Corp · Nov 1994
INJECT-SNARE
K942110 · Endovations · Oct 1994
ENDOSNARE
K923031 · Cook Urological, Inc. · Jun 1993
SNARE FLEXIBLE
K924105 · United States Endoscopy Group, Inc. · Nov 1992
LAPAROSCOPIC SNARE
K911482 · United States Endoscopy Group, Inc. · Apr 1991
DOBBHOFF(R) POLYPECTOMY SNARE
K901322 · Biosearch Medical Products, Inc. · Jun 1990