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FDA 510(k)

MICROPOBE SERIES OF LASERS AND ACCESSORIES

K-Number: K003151 · 2001-01-08

ApplicantEndooptiks, Inc.
Decision Date2001-01-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROPOBE SERIES OF LASERS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Endooptiks, Inc.. It received FDA 510(k) clearance on 2001-01-08 under 510(k) number K003151. 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 MICROPOBE SERIES OF LASERS AND ACCESSORIES?

MICROPOBE SERIES OF LASERS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-01-08. The listed applicant is Endooptiks, Inc.. The 510(k) number is K003151.

When did MICROPOBE SERIES OF LASERS AND ACCESSORIES receive FDA 510(k) clearance?

MICROPOBE SERIES OF LASERS AND ACCESSORIES received FDA 510(k) clearance on 2001-01-08, under 510(k) number K003151.

Who is the listed applicant for MICROPOBE SERIES OF LASERS AND ACCESSORIES?

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

What is the FDA product code for MICROPOBE SERIES OF LASERS AND ACCESSORIES?

The FDA product code for MICROPOBE SERIES OF LASERS AND ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Endooptiks, 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.

K083788ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSRK042918MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2K945081TRANSTYMPANIC ENDOSCOPEK922917ENDOPROBES

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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