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FDA 510(k)

ORION

K-Number: K911288 · 1993-11-16

ApplicantPfizer Laser Systems
Decision Date1993-11-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORION is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Laser Systems. It received FDA 510(k) clearance on 1993-11-16 under 510(k) number K911288. 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 ORION?

ORION is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Pfizer Laser Systems. The 510(k) number is K911288.

When did ORION receive FDA 510(k) clearance?

ORION received FDA 510(k) clearance on 1993-11-16, under 510(k) number K911288.

Who is the listed applicant for ORION?

The FDA 510(k) record lists Pfizer Laser Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION?

The FDA product code for ORION is GEX. This falls under the Gastroenterology category.

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Other records listing Pfizer Laser Systems 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.

K910826ORION YAG LASER SYSTEM OPHTHALMOLOGYK910825ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.K912067POLARIS, GYNECOLOGY INDICATIONSK910152ORIONK912813SIRIUSK911926POLARIS, OPHTHALMOLOGY

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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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