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FDA 510(k)

LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER

K-Number: K921380 · 1992-06-25

ApplicantLaserscope
Decision Date1992-06-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K921380. 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 LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER?

LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Laserscope. The 510(k) number is K921380.

When did LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER receive FDA 510(k) clearance?

LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER received FDA 510(k) clearance on 1992-06-25, under 510(k) number K921380.

Who is the listed applicant for LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER?

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

What is the FDA product code for LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER?

The FDA product code for LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER is GEX. This falls under the Gastroenterology category.

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Other records listing Laserscope 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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