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FDA 510(k)

LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC

K-Number: K891130 · 1989-05-23

ApplicantLifestream Int'L, Inc.
Decision Date1989-05-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC 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 1989-05-23 under 510(k) number K891130. 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 LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC?

LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K891130.

When did LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC receive FDA 510(k) clearance?

LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC received FDA 510(k) clearance on 1989-05-23, under 510(k) number K891130.

Who is the listed applicant for LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC?

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 LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC?

The FDA product code for LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC is GEX. This falls under the Gastroenterology category.

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Other records listing Lifestream Int'L, Inc. as applicant

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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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