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FDA 510(k)

CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC

K-Number: K922881 · 1992-11-16

ApplicantClarus Medical Systems, Inc.
Decision Date1992-11-16
Product CodeGEX
Advisory CommitteeSU
DecisionUnknown

Device Summary

CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-11-16 under 510(k) number K922881. 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: Unknown.

Frequently Asked Questions

What is the CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC?

CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K922881.

When did CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC receive FDA 510(k) clearance?

CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC received FDA 510(k) clearance on 1992-11-16, under 510(k) number K922881.

Who is the listed applicant for CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC?

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

What is the FDA product code for CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC?

The FDA product code for CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC is GEX. This falls under the Gastroenterology category.

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Other records listing Clarus Medical Systems, 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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