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FDA 510(k)

SPIRUS MEDICAL SURGICAL INSTRUMENT

K-Number: K080042 · 2008-04-03

ApplicantSpirus Medical, Inc.
Decision Date2008-04-03
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPIRUS MEDICAL SURGICAL INSTRUMENT 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 2008-04-03 under 510(k) number K080042. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRUS MEDICAL SURGICAL INSTRUMENT?

SPIRUS MEDICAL SURGICAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 2008-04-03. The listed applicant is Spirus Medical, Inc.. The 510(k) number is K080042.

When did SPIRUS MEDICAL SURGICAL INSTRUMENT receive FDA 510(k) clearance?

SPIRUS MEDICAL SURGICAL INSTRUMENT received FDA 510(k) clearance on 2008-04-03, under 510(k) number K080042.

Who is the listed applicant for SPIRUS MEDICAL SURGICAL INSTRUMENT?

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 SPIRUS MEDICAL SURGICAL INSTRUMENT?

The FDA product code for SPIRUS MEDICAL SURGICAL INSTRUMENT is KMJ.

Related Clinical Trials

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.

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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 OVERTUBEK062805MODIFICATION TO ENDO-EASEK060235ENDO-EASE ENDOSCOPIC OVERTUBEK052084ENDO-EASE ENDOSCOPIC OVERTUBE

Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal 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.

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