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FDA 510(k)

CPC PROBE

K-Number: K961380 · 1997-03-17

ApplicantCarl Zeiss, Inc.
Decision Date1997-03-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CPC PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K961380. 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 CPC PROBE?

CPC PROBE is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K961380.

When did CPC PROBE receive FDA 510(k) clearance?

CPC PROBE received FDA 510(k) clearance on 1997-03-17, under 510(k) number K961380.

Who is the listed applicant for CPC PROBE?

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

What is the FDA product code for CPC PROBE?

The FDA product code for CPC PROBE 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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