Cleared Traditional

K051504 - SPYSCOPE ACCESS AND DELIVERY CATHETER

K051504 is an FDA 510(k) clearance for SPYSCOPE ACCESS AND DELIVERY CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K051504 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
9d
Days
Class 2
Risk

K051504 is an FDA 510(k) clearance for the SPYSCOPE ACCESS AND DELIVERY CATHETER. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on June 16, 2005 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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.

FDA 510(k) Submission Details - K051504

510(k) Number K051504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2005
Decision Date June 16, 2005
Days to Decision 9 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 131d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 Consultant

Intertek Testing Services
NEIL E DEVINE

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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 103
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K051504.
USGI TRANSPORT ENDOSCOPIC GUIDE
K061216 · Usgi Medical · May 2006
ENDO-EASE ENDOSCOPIC OVERTUBE
K052084 · Spirus Medical, Inc. · Sep 2005
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
K051919 · Usgi Medical · Jul 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · Cook Urological, Inc. · Mar 2005
USGI SHAPELOCK ENDOSCOPIC GUIDE
K050253 · Usgi Medical · Feb 2005
DISPOSABLE OVERTUBE
K040836 · United States Endoscopy Group, Inc. · Jun 2004

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K051504 · SPYSCOPE ACCESS AND DELIVERY CATHETER
Download PDF FDA Summary Boston Scientific Corp