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FDA 510(k)

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501

K-Number: K991526 · 1999-06-17

ApplicantImagyn Medical Technologies, Inc.
Decision Date1999-06-17
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 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 1999-06-17 under 510(k) number K991526. 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 ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501?

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 is a medical device that received FDA 510(k) clearance on 1999-06-17. The listed applicant is Imagyn Medical Technologies, Inc.. The 510(k) number is K991526.

When did ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 receive FDA 510(k) clearance?

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 received FDA 510(k) clearance on 1999-06-17, under 510(k) number K991526.

Who is the listed applicant for ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501?

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 ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501?

The FDA product code for ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 is KXK.

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Other records listing Imagyn Medical Technologies, Inc. as applicant

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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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