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FDA 510(k)

870 SURGICAL SYS CONTROL PULSE MODIFICATION

K-Number: K852252 · 1985-06-27

ApplicantCooper Lasersonics, Inc.
Decision Date1985-06-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

870 SURGICAL SYS CONTROL PULSE MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1985-06-27 under 510(k) number K852252. 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 870 SURGICAL SYS CONTROL PULSE MODIFICATION?

870 SURGICAL SYS CONTROL PULSE MODIFICATION is a medical device that received FDA 510(k) clearance on 1985-06-27. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K852252.

When did 870 SURGICAL SYS CONTROL PULSE MODIFICATION receive FDA 510(k) clearance?

870 SURGICAL SYS CONTROL PULSE MODIFICATION received FDA 510(k) clearance on 1985-06-27, under 510(k) number K852252.

Who is the listed applicant for 870 SURGICAL SYS CONTROL PULSE MODIFICATION?

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

What is the FDA product code for 870 SURGICAL SYS CONTROL PULSE MODIFICATION?

The FDA product code for 870 SURGICAL SYS CONTROL PULSE MODIFICATION 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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