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FDA 510(k)

LASER SURGICAL ROD

K-Number: K862815 · 1986-11-17

ApplicantLifestream Int'L, Inc.
Decision Date1986-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER SURGICAL ROD is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1986-11-17 under 510(k) number K862815. 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 LASER SURGICAL ROD?

LASER SURGICAL ROD is a medical device that received FDA 510(k) clearance on 1986-11-17. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K862815.

When did LASER SURGICAL ROD receive FDA 510(k) clearance?

LASER SURGICAL ROD received FDA 510(k) clearance on 1986-11-17, under 510(k) number K862815.

Who is the listed applicant for LASER SURGICAL ROD?

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

What is the FDA product code for LASER SURGICAL ROD?

The FDA product code for LASER SURGICAL ROD is GEX. This falls under the Gastroenterology category.

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Other records listing Lifestream Int'L, Inc. 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.

K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920178CARDIOTOMY RESERVOIR W/20 MICRON FILITERK920618AUTOTRANSFUSION SUCTION SETK913181AUTOLOGOUS BLOOD PROCESSING SYSTEMK914396SURGI LIGHT NON-CONTACT FIBERS

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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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