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FDA 510(k)

REPROCESSED TROCARS, MODEL B5LT AND CB5LT

K-Number: K100080 · 2010-03-19

ApplicantAscent Healthcare Solutions
Decision Date2010-03-19
Product CodeNLM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED TROCARS, MODEL B5LT AND CB5LT 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 2010-03-19 under 510(k) number K100080. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED TROCARS, MODEL B5LT AND CB5LT?

REPROCESSED TROCARS, MODEL B5LT AND CB5LT is a medical device that received FDA 510(k) clearance on 2010-03-19. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K100080.

When did REPROCESSED TROCARS, MODEL B5LT AND CB5LT receive FDA 510(k) clearance?

REPROCESSED TROCARS, MODEL B5LT AND CB5LT received FDA 510(k) clearance on 2010-03-19, under 510(k) number K100080.

Who is the listed applicant for REPROCESSED TROCARS, MODEL B5LT AND CB5LT?

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 TROCARS, MODEL B5LT AND CB5LT?

The FDA product code for REPROCESSED TROCARS, MODEL B5LT AND CB5LT is NLM.

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Related Devices (Code: NLM)

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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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