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FDA 510(k)

ANCHORAGE SCOPE, MODEL 000003

K-Number: K080780 · 2008-07-30

ApplicantEpitek, Inc.
Decision Date2008-07-30
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANCHORAGE SCOPE, MODEL 000003 is the device name listed in this FDA 510(k) record. The listed applicant is Epitek, Inc.. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K080780. The device is classified under product code FBO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCHORAGE SCOPE, MODEL 000003?

ANCHORAGE SCOPE, MODEL 000003 is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Epitek, Inc.. The 510(k) number is K080780.

When did ANCHORAGE SCOPE, MODEL 000003 receive FDA 510(k) clearance?

ANCHORAGE SCOPE, MODEL 000003 received FDA 510(k) clearance on 2008-07-30, under 510(k) number K080780.

Who is the listed applicant for ANCHORAGE SCOPE, MODEL 000003?

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

What is the FDA product code for ANCHORAGE SCOPE, MODEL 000003?

The FDA product code for ANCHORAGE SCOPE, MODEL 000003 is FBO.

Related Clinical Trials

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Other records listing Epitek, 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.

K073507ANCHORAGE ACCESS KITK073096ANCHORAGE CLOSURE DEVICE

Related Devices (Code: FBO)

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.

K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)Karl Storz SE & CO. KGK243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KGK082046KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOKARL STORZ Endoscopy-America, Inc.K062918KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.K061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESLaserscopeK011496CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660Richard Wolf Medical Instruments Corp.

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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