Cleared Traditional

Niti-S Biliary Slim M Stent (K221071) - FDA 510(k) Clearance

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

K221071 · Taewoong Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
58d
Days
Class 2
Risk

K221071 is an FDA 510(k) clearance for the Niti-S Biliary Slim M Stent. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Taewoong Medical Co., Ltd. (Gimpo-Si, KR). The FDA issued a Cleared decision on June 9, 2022 after a review of 58 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 Taewoong Medical Co., Ltd. devices

Submission Details

510(k) Number K221071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 12, 2022
Decision Date June 09, 2022
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
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 Consultant

Biologics Consulting Group, Inc.
Matthew Krueger

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 212
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K221071.
MultiStage Balloon Dilatation Catheter
K222663 · Dongguan TT Medical, Inc. · Mar 2023
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
K223592 · Boston Scientific Corporation · Dec 2022
EndoGI S-Path Biliary Stent System
K222627 · Endo GI Medical · Sep 2022
Compass BDS Biliary Stent
K213946 · Cook Ireland, Ltd. · May 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
K211021 · Micro-Tech (Nanjing) Co., Ltd. · May 2022
BIOTEQ Drainage Catheter BT-PDS-series
K210419 · Bioteque Corporation · Apr 2022