FDA 510(k)

REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

K-Number: K012625 · 2001-10-22

Decision Date2001-10-22

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical Corp.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K012625. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS?

REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Alliance Medical Corp.. The 510(k) number is K012625.

When did REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012625.

Who is the listed applicant for REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS?

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

What is the FDA product code for REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS?

The FDA product code for REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS is GEI.

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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.