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FDA 510(k)

INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM

K-Number: K992262 · 1999-10-04

ApplicantIndigo Medical, Inc.
Decision Date1999-10-04
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Indigo Medical, Inc.. It received FDA 510(k) clearance on 1999-10-04 under 510(k) number K992262. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM?

INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-04. The listed applicant is Indigo Medical, Inc.. The 510(k) number is K992262.

When did INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM receive FDA 510(k) clearance?

INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM received FDA 510(k) clearance on 1999-10-04, under 510(k) number K992262.

Who is the listed applicant for INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM?

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

What is the FDA product code for INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM?

The FDA product code for INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM is KXK.

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Other records listing Indigo 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.

K990851INDIGO LASEROPTIC TREATMENT SYSTEMK963969INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIBK963081INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONSK955758INDIGO MEDICAL MODEL IDL 830EK954195INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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