FDA 510(k)

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218

K-Number: K003056 · 2000-12-13

ApplicantLabotect Labor-Technik Gottingen

Decision Date2000-12-13

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 is the device name listed in this FDA 510(k) record. The listed applicant is Labotect Labor-Technik Gottingen. It received FDA 510(k) clearance on 2000-12-13 under 510(k) number K003056. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218?

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Labotect Labor-Technik Gottingen. The 510(k) number is K003056.

When did OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 receive FDA 510(k) clearance?

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 received FDA 510(k) clearance on 2000-12-13, under 510(k) number K003056.

Who is the listed applicant for OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218?

The FDA 510(k) record lists Labotect Labor-Technik Gottingen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218?

The FDA product code for OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 is MQE.

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Other records listing Labotect Labor-Technik Gottingen as applicant

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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.