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FDA 510(k)

INTRAUTERINE DELIVERY SYSTEM - INJECTOR

K-Number: K023051 · 2002-12-12

ApplicantProsurg, Inc.
Decision Date2002-12-12
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRAUTERINE DELIVERY SYSTEM - INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2002-12-12 under 510(k) number K023051. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAUTERINE DELIVERY SYSTEM - INJECTOR?

INTRAUTERINE DELIVERY SYSTEM - INJECTOR is a medical device that received FDA 510(k) clearance on 2002-12-12. The listed applicant is Prosurg, Inc.. The 510(k) number is K023051.

When did INTRAUTERINE DELIVERY SYSTEM - INJECTOR receive FDA 510(k) clearance?

INTRAUTERINE DELIVERY SYSTEM - INJECTOR received FDA 510(k) clearance on 2002-12-12, under 510(k) number K023051.

Who is the listed applicant for INTRAUTERINE DELIVERY SYSTEM - INJECTOR?

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

What is the FDA product code for INTRAUTERINE DELIVERY SYSTEM - INJECTOR?

The FDA product code for INTRAUTERINE DELIVERY SYSTEM - INJECTOR is LKF.

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Related Devices (Code: LKF)

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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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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