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FDA 510(k)

REPROCESSED HAND ACTIVATE SEALER/DIVIDER

K-Number: K111600 · 2011-11-15

ApplicantAscent Healthcare Solutions
Decision Date2011-11-15
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED HAND ACTIVATE 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 2011-11-15 under 510(k) number K111600. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED HAND ACTIVATE SEALER/DIVIDER?

REPROCESSED HAND ACTIVATE SEALER/DIVIDER is a medical device that received FDA 510(k) clearance on 2011-11-15. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K111600.

When did REPROCESSED HAND ACTIVATE SEALER/DIVIDER receive FDA 510(k) clearance?

REPROCESSED HAND ACTIVATE SEALER/DIVIDER received FDA 510(k) clearance on 2011-11-15, under 510(k) number K111600.

Who is the listed applicant for REPROCESSED HAND ACTIVATE 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 HAND ACTIVATE SEALER/DIVIDER?

The FDA product code for REPROCESSED HAND ACTIVATE SEALER/DIVIDER is NUJ.

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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.

K110189REPROCESSED 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 CB5LTK093702REPROCESSED ULTRASONIC COAGULATING SHEARS

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Related Devices (Code: NUJ)

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.

K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLCK191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLCK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren

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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