Cleared Traditional

LUNDERQUIST - RING PTC DRAINAGE CATHETER (K861220) - FDA 510(k) Clearance

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

K861220 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
48d
Days
Class 2
Risk

K861220 is an FDA 510(k) clearance for the LUNDERQUIST - RING PTC DRAINAGE CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on May 19, 1986 after a review of 48 days - a notably fast clearance 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: 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 Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K861220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1986
Decision Date May 19, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 181
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K861220.
COOK-GIANTURCO BILIARY Z STENT
K882610 · Cook, Inc. · Apr 1989
MODIFIED COPE SUTURE ANCHOR
K873606 · Cook, Inc. · Jun 1988
BARD BALLOON DILATATION SYSTEM
K863437 · C.R. Bard, Inc. · Oct 1986
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · C.R. Bard, Inc. · Sep 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · Cook, Inc. · Sep 1985