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FDA 510(k)

ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213

K-Number: K082156 · 2008-09-10

ApplicantTeleflex Medical
Decision Date2008-09-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2008-09-10 under 510(k) number K082156. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213?

ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 is a medical device that received FDA 510(k) clearance on 2008-09-10. The listed applicant is Teleflex Medical. The 510(k) number is K082156.

When did ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 receive FDA 510(k) clearance?

ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 received FDA 510(k) clearance on 2008-09-10, under 510(k) number K082156.

Who is the listed applicant for ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213?

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

What is the FDA product code for ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213?

The FDA product code for ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 is GCJ.

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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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