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FDA 510(k)

STRAIGHT FIRE HOLMIUM LASER FIBER

K-Number: K082928 · 2008-10-16

ApplicantBoston Scientific Corp
Decision Date2008-10-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRAIGHT FIRE HOLMIUM LASER FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2008-10-16 under 510(k) number K082928. 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 STRAIGHT FIRE HOLMIUM LASER FIBER?

STRAIGHT FIRE HOLMIUM LASER FIBER is a medical device that received FDA 510(k) clearance on 2008-10-16. The listed applicant is Boston Scientific Corp. The 510(k) number is K082928.

When did STRAIGHT FIRE HOLMIUM LASER FIBER receive FDA 510(k) clearance?

STRAIGHT FIRE HOLMIUM LASER FIBER received FDA 510(k) clearance on 2008-10-16, under 510(k) number K082928.

Who is the listed applicant for STRAIGHT FIRE HOLMIUM LASER FIBER?

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

What is the FDA product code for STRAIGHT FIRE HOLMIUM LASER FIBER?

The FDA product code for STRAIGHT FIRE HOLMIUM LASER FIBER 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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