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FDA 510(k)

MODEL 120-SC LASER DELIVERY PROBE

K-Number: K944631 · 1994-11-01

ApplicantMnlase, Inc.
Decision Date1994-11-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 120-SC LASER DELIVERY PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1994-11-01 under 510(k) number K944631. 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 MODEL 120-SC LASER DELIVERY PROBE?

MODEL 120-SC LASER DELIVERY PROBE is a medical device that received FDA 510(k) clearance on 1994-11-01. The listed applicant is Mnlase, Inc.. The 510(k) number is K944631.

When did MODEL 120-SC LASER DELIVERY PROBE receive FDA 510(k) clearance?

MODEL 120-SC LASER DELIVERY PROBE received FDA 510(k) clearance on 1994-11-01, under 510(k) number K944631.

Who is the listed applicant for MODEL 120-SC LASER DELIVERY PROBE?

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

What is the FDA product code for MODEL 120-SC LASER DELIVERY PROBE?

The FDA product code for MODEL 120-SC LASER DELIVERY PROBE is GEX. This falls under the Gastroenterology category.

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Other records listing Mnlase, 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.

K944630MODEL 230-SAS LASER DELIVERY PROBEK944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASERK944628MODEL 220-SS LASER DELIVERY PROBEK944470CURVED ENDOPHOTOCOAGULATOR LASER PROBEK944471STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBEK944629MODEL 230-SAC LASER DELIVERY PROBE

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Related Devices (Code: GEX)

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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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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