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FDA 510(k)

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

K-Number: K010166 · 2001-12-03

ApplicantImagyn Medical Technologies, Inc.
Decision Date2001-12-03
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical Technologies, Inc.. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K010166. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM?

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Imagyn Medical Technologies, Inc.. The 510(k) number is K010166.

When did IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM receive FDA 510(k) clearance?

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM received FDA 510(k) clearance on 2001-12-03, under 510(k) number K010166.

Who is the listed applicant for IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM?

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

What is the FDA product code for IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM?

The FDA product code for IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM is IWJ.

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Other records listing Imagyn Medical Technologies, 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.

K032491ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITORK012706IM2001 PULSE OXIMETERK991526ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501K980096OAC (OPTICAL ASPIRATING CURETTE)K980291IMPOWER EXTERNAL VACUUM SYSTEMK974173ERECAID SYSTEM/STAY EREC SYSTEM

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Related Devices (Code: IWJ)

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.

K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLCK973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy ProductsK973638N.I.T., INC. NEEDLE GUIDING TEMPLATEAvid N.I.T., 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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