FDA 510(k)

ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)

K-Number: K970875 · 1997-05-20

Decision Date1997-05-20

Product CodeMPA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Devices, Inc.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K970875. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)?

ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is American Medical Devices, Inc.. The 510(k) number is K970875.

When did ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) receive FDA 510(k) clearance?

ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) received FDA 510(k) clearance on 1997-05-20, under 510(k) number K970875.

Who is the listed applicant for ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)?

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

What is the FDA product code for ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)?

The FDA product code for ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) is MPA.

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Other records listing American Medical Devices, Inc. as applicant

K974561MOISTAIR FLUID AIR TUBING SET K971853ENDOVIEW SPPHIRE LENS SET K970882ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)K970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)K970878ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT

Related Devices (Code: MPA)

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLC K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional

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.