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FDA 510(k)

AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING

K-Number: K111285 · 2011-09-09

ApplicantSalient Surgical Technologies, Inc.
Decision Date2011-09-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING is the device name listed in this FDA 510(k) record. The listed applicant is Salient Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K111285. 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 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING?

AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Salient Surgical Technologies, Inc.. The 510(k) number is K111285.

When did AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING receive FDA 510(k) clearance?

AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING received FDA 510(k) clearance on 2011-09-09, under 510(k) number K111285.

Who is the listed applicant for AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING?

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

What is the FDA product code for AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING?

The FDA product code for AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING is GEI.

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Other records listing Salient Surgical Technologies, Inc. as applicant

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.

K111732AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER

Related Devices (Code: GEI)

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Official Source

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