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FDA 510(k)

MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2

K-Number: K042918 · 2004-11-22

ApplicantEndooptiks, Inc.
Decision Date2004-11-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 is the device name listed in this FDA 510(k) record. The listed applicant is Endooptiks, Inc.. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K042918. 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 MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2?

MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Endooptiks, Inc.. The 510(k) number is K042918.

When did MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 receive FDA 510(k) clearance?

MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 received FDA 510(k) clearance on 2004-11-22, under 510(k) number K042918.

Who is the listed applicant for MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2?

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 MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2?

The FDA product code for MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 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 SESSRK003151MICROPOBE SERIES OF LASERS AND ACCESSORIESK945081TRANSTYMPANIC ENDOSCOPEK922917ENDOPROBES

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Official Source

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