Cleared Traditional

URETERAL ACCESS SHEATH SET - NEW MODELS (K993650) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993650 · Applied Medical Resources · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
60d
Days
Class 2
Risk

K993650 is an FDA 510(k) clearance for the URETERAL ACCESS SHEATH SET - NEW MODELS. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on December 28, 1999 after a review of 60 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.

View all Applied Medical Resources devices

Submission Details

510(k) Number K993650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1999
Decision Date December 28, 1999
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 51
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K993650.
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
K033778 · C.R. Bard, Inc. · Dec 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · Boston Scientific Corp · May 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · C.R. Bard, Inc. · Mar 2003
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · C.R. Bard, Inc. · Oct 1997
BARD ENDOSCOPIC OVERTUBE
K942044 · C.R. Bard, Inc. · Jun 1994
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
K921120 · Cook Urological, Inc. · Aug 1992