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FDA 510(k)

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE

K-Number: K080731 · 2008-07-17

ApplicantOsyris
Decision Date2008-07-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Osyris. It received FDA 510(k) clearance on 2008-07-17 under 510(k) number K080731. 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 PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE?

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Osyris. The 510(k) number is K080731.

When did PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE receive FDA 510(k) clearance?

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE received FDA 510(k) clearance on 2008-07-17, under 510(k) number K080731.

Who is the listed applicant for PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE?

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

What is the FDA product code for PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE?

The FDA product code for PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Osyris 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.

K082004SMOOTHKIT+K073617PHARAON LIPO

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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