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FDA 510(k)

AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1

K-Number: K101057 · 2011-04-05

ApplicantSalient Surgical Technologies
Decision Date2011-04-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 is the device name listed in this FDA 510(k) record. The listed applicant is Salient Surgical Technologies. It received FDA 510(k) clearance on 2011-04-05 under 510(k) number K101057. 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 AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1?

AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 is a medical device that received FDA 510(k) clearance on 2011-04-05. The listed applicant is Salient Surgical Technologies. The 510(k) number is K101057.

When did AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 receive FDA 510(k) clearance?

AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 received FDA 510(k) clearance on 2011-04-05, under 510(k) number K101057.

Who is the listed applicant for AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1?

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

What is the FDA product code for AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1?

The FDA product code for AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 is GEI.

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Official Source

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