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FDA 510(k)

ENDO-EASE ENDOSCOPIC OVERTUBE

K-Number: K060235 · 2006-08-04

ApplicantSpirus Medical, Inc.
Decision Date2006-08-04
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO-EASE ENDOSCOPIC OVERTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Spirus Medical, Inc.. It received FDA 510(k) clearance on 2006-08-04 under 510(k) number K060235. 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 ENDO-EASE ENDOSCOPIC OVERTUBE?

ENDO-EASE ENDOSCOPIC OVERTUBE is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Spirus Medical, Inc.. The 510(k) number is K060235.

When did ENDO-EASE ENDOSCOPIC OVERTUBE receive FDA 510(k) clearance?

ENDO-EASE ENDOSCOPIC OVERTUBE received FDA 510(k) clearance on 2006-08-04, under 510(k) number K060235.

Who is the listed applicant for ENDO-EASE ENDOSCOPIC OVERTUBE?

The FDA 510(k) record lists Spirus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO-EASE ENDOSCOPIC OVERTUBE?

The FDA product code for ENDO-EASE ENDOSCOPIC OVERTUBE is FDA.

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Other records listing Spirus Medical, Inc. 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.

K080050SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBEK080042SPIRUS MEDICAL SURGICAL INSTRUMENTK062805MODIFICATION TO ENDO-EASEK052084ENDO-EASE ENDOSCOPIC OVERTUBE

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

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

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