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FDA 510(k)

CELL ROBOTICS' LASETTE

K-Number: K981746 · 1998-12-07

ApplicantCell Robotics, Inc.
Decision Date1998-12-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CELL ROBOTICS' LASETTE is the device name listed in this FDA 510(k) record. The listed applicant is Cell Robotics, Inc.. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K981746. 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 CELL ROBOTICS' LASETTE?

CELL ROBOTICS' LASETTE is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Cell Robotics, Inc.. The 510(k) number is K981746.

When did CELL ROBOTICS' LASETTE receive FDA 510(k) clearance?

CELL ROBOTICS' LASETTE received FDA 510(k) clearance on 1998-12-07, under 510(k) number K981746.

Who is the listed applicant for CELL ROBOTICS' LASETTE?

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

What is the FDA product code for CELL ROBOTICS' LASETTE?

The FDA product code for CELL ROBOTICS' LASETTE is GEX. This falls under the Gastroenterology category.

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Other records listing Cell Robotics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

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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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