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FDA 510(k)

SCION BALLOON ELEVATOR

K-Number: K973698 · 1998-03-31

ApplicantScion International, Inc.
Decision Date1998-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCION BALLOON ELEVATOR 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 1998-03-31 under 510(k) number K973698. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCION BALLOON ELEVATOR?

SCION BALLOON ELEVATOR is a medical device that received FDA 510(k) clearance on 1998-03-31. The listed applicant is Scion International, Inc.. The 510(k) number is K973698.

When did SCION BALLOON ELEVATOR receive FDA 510(k) clearance?

SCION BALLOON ELEVATOR received FDA 510(k) clearance on 1998-03-31, under 510(k) number K973698.

Who is the listed applicant for SCION BALLOON ELEVATOR?

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 BALLOON ELEVATOR?

The FDA product code for SCION BALLOON ELEVATOR is GCJ.

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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.

K040087RABBITK973652DUOCLIPPER TITANIUM CLIPSK963006SCION SAPHENOUS VEIN HARVESTING SYSTEM

Related Devices (Code: GCJ)

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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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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