FDA 510(k)

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM

K-Number: K000608 · 2000-03-07

Decision Date2000-03-07

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Std Mfg., Inc.. It received FDA 510(k) clearance on 2000-03-07 under 510(k) number K000608. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM?

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-07. The listed applicant is Std Mfg., Inc.. The 510(k) number is K000608.

When did SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM receive FDA 510(k) clearance?

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM received FDA 510(k) clearance on 2000-03-07, under 510(k) number K000608.

Who is the listed applicant for SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM?

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

What is the FDA product code for SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM?

The FDA product code for SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM is GDW.

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Other records listing Std Mfg., Inc. as applicant

K023096CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM K021549CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM K012362MODIFICATION TO VASCULAR CLOSURE DEVICE K003169VASCULAR CLOSURE DEVICE K930427STD IRRIGATION PUMP

Related Devices (Code: GDW)

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.