Cleared Traditional

K251204 - FUJIFILM Stiffening Wire Device (SW-2000) (FDA 510(k) Clearance)

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

K251204 · Fujifilm Healthcare Americas Corporation · Gastroenterology & Urology device
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Sep 2025
Decision
161d
Days
Class 2
Risk

K251204 is an FDA 510(k) clearance for the FUJIFILM Stiffening Wire Device (SW-2000). Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on September 26, 2025 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Fujifilm Healthcare Americas Corporation devices

Submission Details

510(k) Number K251204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2025
Decision Date September 26, 2025
Days to Decision 161 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
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDA Enteroscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Visualization And Perform Various Procedures Within The Small Intestine. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDA Enteroscope And Accessories

All 19
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K251204.
Ancora-SB
K260314 · Aspero Medical, Inc. · May 2026
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · Fujifilm Healthcare Americas Corporation · Jun 2024
Ancora-SB
K231323 · Aspero Medical, Inc. · Aug 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
K223295 · Fujifilm Corporaton · Jan 2023
Balloon BS-3
K213195 · Fujifilm Corporation · Oct 2021