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FDA 510(k)

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES

K-Number: K121187 · 2012-09-17

ApplicantKatalyst Surgical, LLC
Decision Date2012-09-17
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst Surgical, LLC. It received FDA 510(k) clearance on 2012-09-17 under 510(k) number K121187. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES?

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES is a medical device that received FDA 510(k) clearance on 2012-09-17. The listed applicant is Katalyst Surgical, LLC. The 510(k) number is K121187.

When did KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES receive FDA 510(k) clearance?

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES received FDA 510(k) clearance on 2012-09-17, under 510(k) number K121187.

Who is the listed applicant for KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES?

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

What is the FDA product code for KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES?

The FDA product code for KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES is HQF.

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Official Source

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