Cleared Traditional

K252648 - Niti-S SPAXUS Stent (FDA 510(k) Clearance)

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

K252648 · Taewoong Medical Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
204d
Days
Class 2
Risk

K252648 is an FDA 510(k) clearance for the Niti-S SPAXUS Stent. Classified as Pancreatic Stent, Covered, Metallic, Removable (product code PCU), Class II - Special Controls.

Submitted by Taewoong Medical Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 13, 2026 after a review of 204 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5015 - 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 Taewoong Medical Co., Ltd. devices

Submission Details

510(k) Number K252648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2025
Decision Date March 13, 2026
Days to Decision 204 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
74d slower than avg
Panel avg: 130d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCU Pancreatic Stent, Covered, Metallic, Removable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5015
Definition To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts
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
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.