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FDA 510(k)

SURGIFLEX LASER CONTACT TIPS

K-Number: K894186 · 1989-09-12

ApplicantCabot Medical Corp.
Decision Date1989-09-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIFLEX LASER CONTACT TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Cabot Medical Corp.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K894186. 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 SURGIFLEX LASER CONTACT TIPS?

SURGIFLEX LASER CONTACT TIPS is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Cabot Medical Corp.. The 510(k) number is K894186.

When did SURGIFLEX LASER CONTACT TIPS receive FDA 510(k) clearance?

SURGIFLEX LASER CONTACT TIPS received FDA 510(k) clearance on 1989-09-12, under 510(k) number K894186.

Who is the listed applicant for SURGIFLEX LASER CONTACT TIPS?

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

What is the FDA product code for SURGIFLEX LASER CONTACT TIPS?

The FDA product code for SURGIFLEX LASER CONTACT TIPS is GEX. This falls under the Gastroenterology category.

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Other records listing Cabot Medical Corp. 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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