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FDA 510(k)

SCION SAPHENOUS VEIN HARVESTING SYSTEM

K-Number: K963006 · 1996-09-20

ApplicantScion International, Inc.
Decision Date1996-09-20
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCION SAPHENOUS VEIN HARVESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scion International, Inc.. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K963006. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCION SAPHENOUS VEIN HARVESTING SYSTEM?

SCION SAPHENOUS VEIN HARVESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Scion International, Inc.. The 510(k) number is K963006.

When did SCION SAPHENOUS VEIN HARVESTING SYSTEM receive FDA 510(k) clearance?

SCION SAPHENOUS VEIN HARVESTING SYSTEM received FDA 510(k) clearance on 1996-09-20, under 510(k) number K963006.

Who is the listed applicant for SCION SAPHENOUS VEIN HARVESTING SYSTEM?

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

What is the FDA product code for SCION SAPHENOUS VEIN HARVESTING SYSTEM?

The FDA product code for SCION SAPHENOUS VEIN HARVESTING SYSTEM is GAD.

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Other records listing Scion International, 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.

K040087RABBITK973698SCION BALLOON ELEVATORK973652DUOCLIPPER TITANIUM CLIPS

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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