Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUJIFILM Stiffening Wire Device (SW-2000)

K-Number: K251204 · 2025-09-26

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2025-09-26
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Stiffening Wire Device (SW-2000) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251204. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Stiffening Wire Device (SW-2000)?

FUJIFILM Stiffening Wire Device (SW-2000) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K251204.

When did FUJIFILM Stiffening Wire Device (SW-2000) receive FDA 510(k) clearance?

FUJIFILM Stiffening Wire Device (SW-2000) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251204.

Who is the listed applicant for FUJIFILM Stiffening Wire Device (SW-2000)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Stiffening Wire Device (SW-2000)?

The FDA product code for FUJIFILM Stiffening Wire Device (SW-2000) is FDA.

Other records listing FUJIFILM Healthcare Americas Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261713Synapse PACS (7.6.0)K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CK233629APERTO Lucent MRI SystemK233687ECHELON Synergy V10.0K233583FCT iSTREAM Phase 1

View all 13 devices →

Related Devices (Code: FDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260314Ancora-SBAspero Medical, Inc.K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm CorporatonK213195Balloon BS-3Fujifilm CorporationK191330Arc EnterocuffBoddingtons Plastics, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑