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FDA 510(k)

REPROCESSED LIGASURE VESSEL SEALER/DIVIDER

K-Number: K062525 · 2007-05-16

ApplicantAscent Healthcare Solutions
Decision Date2007-05-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED LIGASURE VESSEL SEALER/DIVIDER is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Healthcare Solutions. It received FDA 510(k) clearance on 2007-05-16 under 510(k) number K062525. 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 LIGASURE VESSEL SEALER/DIVIDER?

REPROCESSED LIGASURE VESSEL SEALER/DIVIDER is a medical device that received FDA 510(k) clearance on 2007-05-16. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K062525.

When did REPROCESSED LIGASURE VESSEL SEALER/DIVIDER receive FDA 510(k) clearance?

REPROCESSED LIGASURE VESSEL SEALER/DIVIDER received FDA 510(k) clearance on 2007-05-16, under 510(k) number K062525.

Who is the listed applicant for REPROCESSED LIGASURE VESSEL SEALER/DIVIDER?

The FDA 510(k) record lists Ascent Healthcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED LIGASURE VESSEL SEALER/DIVIDER?

The FDA product code for REPROCESSED LIGASURE VESSEL SEALER/DIVIDER is GEI.

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Other records listing Ascent Healthcare Solutions 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.

K111600REPROCESSED HAND ACTIVATE SEALER/DIVIDERK110189REPROCESSED ELECTROSURGICAL INSTRUMENTK100909REPROCESSED COMPRESSION SLEEVESK100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERK100537REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUEK100080REPROCESSED TROCARS, MODEL B5LT AND CB5LT

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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