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FDA 510(k)

AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER

K-Number: K111732 · 2011-12-05

ApplicantSalient Surgical Technologies, Inc.
Decision Date2011-12-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER 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 2011-12-05 under 510(k) number K111732. 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 SBS 5.0 SHEATED BIOPOLAR SEALER?

AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER is a medical device that received FDA 510(k) clearance on 2011-12-05. The listed applicant is Salient Surgical Technologies, Inc.. The 510(k) number is K111732.

When did AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER receive FDA 510(k) clearance?

AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER received FDA 510(k) clearance on 2011-12-05, under 510(k) number K111732.

Who is the listed applicant for AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER?

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 SBS 5.0 SHEATED BIOPOLAR SEALER?

The FDA product code for AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER 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.

K111285AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING

Related Devices (Code: GEI)

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.

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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.

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