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FDA 510(k)

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM

K-Number: K153063 · 2016-04-08

ApplicantTeleflexmedical, Inc.
Decision Date2016-04-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153063. 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 PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM?

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K153063.

When did PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM receive FDA 510(k) clearance?

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153063.

Who is the listed applicant for PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM?

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

What is the FDA product code for PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM?

The FDA product code for PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is GEI.

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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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