Cleared Traditional

K862059 - SHEATH, ENDOSCOPE

K862059 is an FDA 510(k) clearance for SHEATH, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K862059 · Endovations · Gastroenterology & Urology device
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Nov 1986
Decision
158d
Days
Class 2
Risk

K862059 is an FDA 510(k) clearance for the SHEATH, ENDOSCOPE. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on November 4, 1986 after a review of 158 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Endovations devices

FDA 510(k) Submission Details - K862059

510(k) Number K862059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date November 04, 1986
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 131d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 404
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K862059.
MODIFIED COPE SUTURE ANCHOR
K873606 · Cook, Inc. · Jun 1988
NAMIC HAWKINS UNIVERSAL DRAINAGE SET
K873954 · North American Instrument Corp. · Jan 1988
LINDEN STONE EXTRACTION BALLOON
K872509 · Hobbs Medical, Inc. · Sep 1987
BILIARY BALLOON CATHETER
K863571 · Uresil Corp. · Nov 1986
BARD BALLOON DILATATION SYSTEM
K863437 · C.R. Bard, Inc. · Oct 1986
LUNDERQUIST - RING PTC DRAINAGE CATHETER
K861220 · Meadox Surgimed, Inc. · May 1986