Cleared Traditional

K002018 - NDO SURGICAL SURGICAL OVERTUBE

K002018 is an FDA 510(k) clearance for NDO SURGICAL SURGICAL OVERTUBE, manufactured by Surgical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K002018 · Surgical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
45d
Days
Class 2
Risk

K002018 is an FDA 510(k) clearance for the NDO SURGICAL SURGICAL OVERTUBE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Surgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on August 17, 2000 after a review of 45 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 Surgical, Inc. devices

FDA 510(k) Submission Details - K002018

510(k) Number K002018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date August 17, 2000
Days to Decision 45 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
85d faster than avg
Panel avg: 130d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 67
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K002018.
DEFLECTING URETERAL ACCESS SHEATH
K030642 · Applied Medical Resources Corp. · May 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · Boston Scientific Corp · May 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · C.R. Bard, Inc. · Mar 2003
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · Applied Medical Resources · Dec 1999
URETERAL ACCESS SHEATH SET
K990775 · Applied Medical Resources · Apr 1999
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · C.R. Bard, Inc. · Oct 1997