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FDA 510(k)

INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP

K-Number: K970754 · 1997-04-21

ApplicantInnerdyne, Inc.
Decision Date1997-04-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne, Inc.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970754. 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 STEP TROCAR EXPANABLE PORT, OPEN STEP?

INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Innerdyne, Inc.. The 510(k) number is K970754.

When did INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP receive FDA 510(k) clearance?

INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970754.

Who is the listed applicant for INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP?

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 STEP TROCAR EXPANABLE PORT, OPEN STEP?

The FDA product code for INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP 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 DEVICEK990493INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICEK982417INNERDYNE STEP TROCAR EXPANDABLE PORT, STEPK980578INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)K972684INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM

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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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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