Cleared Traditional

K901433 - SURE-FLEX ANASTOMOTIC BALLOON DILATOR

K901433 is an FDA 510(k) clearance for SURE-FLEX ANASTOMOTIC BALLOON DILATOR, manufactured by Telemed Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K901433 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
87d
Days
Class 2
Risk

K901433 is an FDA 510(k) clearance for the SURE-FLEX ANASTOMOTIC BALLOON DILATOR. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 21, 1990 after a review of 87 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K901433

510(k) Number K901433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 21, 1990
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 335
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K901433.
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
K901427 · Telemed Systems, Inc. · Jun 1990
DOBBHOFF BILIARY STENT SET
K901582 · Biosearch Medical Products, Inc. · Jun 1990
BILIARY BALLOON DILATOR
K901432 · Telemed Systems, Inc. · Jun 1990
TELEMED ERCP CANNULA
K901431 · Telemed Systems, Inc. · Jun 1990
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
K900904 · Candela Laser Corp. · May 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · Wilson-Cook Medical, Inc. · Apr 1990