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)

SIF-SW

K-Number: K904800 · 1991-03-27

ApplicantOlympus Corp.
Decision Date1991-03-27
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIF-SW is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K904800. 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 SIF-SW?

SIF-SW is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is Olympus Corp.. The 510(k) number is K904800.

When did SIF-SW receive FDA 510(k) clearance?

SIF-SW received FDA 510(k) clearance on 1991-03-27, under 510(k) number K904800.

Who is the listed applicant for SIF-SW?

The FDA 510(k) record lists Olympus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIF-SW?

The FDA product code for SIF-SW is FDA.

Other records listing Olympus Corp. 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

View all 142 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.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas CorporationK233321Double 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 Corporation

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.

↑