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FDA 510(k)

INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE

K-Number: K990493 · 1999-05-18

ApplicantInnerdyne, Inc.
Decision Date1999-05-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne, Inc.. It received FDA 510(k) clearance on 1999-05-18 under 510(k) number K990493. 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 INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE?

INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE is a medical device that received FDA 510(k) clearance on 1999-05-18. The listed applicant is Innerdyne, Inc.. The 510(k) number is K990493.

When did INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE receive FDA 510(k) clearance?

INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE received FDA 510(k) clearance on 1999-05-18, under 510(k) number K990493.

Who is the listed applicant for INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE?

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

What is the FDA product code for INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE?

The FDA product code for INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE is GCJ.

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Other records listing Innerdyne, 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.

K992668INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)K990854INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICEK982417INNERDYNE STEP TROCAR EXPANDABLE PORT, STEPK980578INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)K972684INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEMK971230SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT

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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

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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