Cleared Traditional

K900904 - CANDELA DIRECTABLE BILIARY CATHETER SYSTEM

K900904 is an FDA 510(k) clearance for CANDELA DIRECTABLE BILIARY CATHETER SYSTEM, manufactured by Candela Laser Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K900904 · Candela Laser Corp. · Gastroenterology & Urology device
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May 1990
Decision
73d
Days
Class 2
Risk

K900904 is an FDA 510(k) clearance for the CANDELA DIRECTABLE BILIARY CATHETER SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on May 11, 1990 after a review of 73 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 Candela Laser Corp. devices

FDA 510(k) Submission Details - K900904

510(k) Number K900904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date May 11, 1990
Days to Decision 73 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
58d faster than avg
Panel avg: 131d · This submission: 73d
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 400
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K900904.
BILIARY BALLOON DILATOR
K901432 · Telemed Systems, Inc. · Jun 1990
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
K901433 · Telemed Systems, Inc. · Jun 1990
TELEMED ERCP CANNULA
K901431 · Telemed Systems, Inc. · Jun 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · Wilson-Cook Medical, Inc. · Apr 1990
BARD/ANGIOMED STENTS
K896391 · C.R. Bard, Inc. · Mar 1990
DOBBHOFF(R) ERCP CANNULA
K896518 · Biosearch Medical Products, Inc. · Feb 1990