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FDA 510(k)

SINGLE STICK RADIALLY EXPANDING DILATOR

K-Number: K943056 · 1994-09-27

ApplicantInnerdyne Medical, Inc.
Decision Date1994-09-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE STICK RADIALLY EXPANDING DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne Medical, Inc.. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K943056. 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 SINGLE STICK RADIALLY EXPANDING DILATOR?

SINGLE STICK RADIALLY EXPANDING DILATOR is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Innerdyne Medical, Inc.. The 510(k) number is K943056.

When did SINGLE STICK RADIALLY EXPANDING DILATOR receive FDA 510(k) clearance?

SINGLE STICK RADIALLY EXPANDING DILATOR received FDA 510(k) clearance on 1994-09-27, under 510(k) number K943056.

Who is the listed applicant for SINGLE STICK RADIALLY EXPANDING DILATOR?

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

What is the FDA product code for SINGLE STICK RADIALLY EXPANDING DILATOR?

The FDA product code for SINGLE STICK RADIALLY EXPANDING DILATOR is GCJ.

Related Clinical Trials

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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Other records listing Innerdyne Medical, 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.

K943253INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.K940428INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATORK940232INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.K932692INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KITK931489INTHERM RADIALLY EXPANDING DILATING INTRODUCER

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

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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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