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FDA 510(k)

PITANGA

K-Number: K031489 · 2003-08-19

ApplicantSyneron Medical, Ltd.
Decision Date2003-08-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PITANGA is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2003-08-19 under 510(k) number K031489. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PITANGA?

PITANGA is a medical device that received FDA 510(k) clearance on 2003-08-19. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K031489.

When did PITANGA receive FDA 510(k) clearance?

PITANGA received FDA 510(k) clearance on 2003-08-19, under 510(k) number K031489.

Who is the listed applicant for PITANGA?

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

What is the FDA product code for PITANGA?

The FDA product code for PITANGA is GEX. This falls under the Gastroenterology category.

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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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