Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001

Q: What is the product code of K000416?

The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.

FDA 510(k) K000416 · Retinalabs.Com

Substantially Equivalent

510(k) numberK000416

Submission

Device name: Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001
Applicant: Retinalabs.Com
Atlanta, GA, US
Received: February 8, 2000
Decision date: May 8, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MPA – Endoilluminator
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Specialty: Gastroenterology, Urology

Other 510(k)s with product code MPA

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K242184	Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional	Alcon Laboratories, Inc.	12/04/2024SE
K233653	Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…MPA · Traditional	Peregrine Surgical, LLC	08/05/2024SE
K221872	ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemMPA · Abbreviated	Nova Eye Inc. (Business Name Nova Eye Medical)	03/30/2023SE
K202670	Nam illumination probe with chopperMPA · Traditional	Oculight , Ltd.	08/20/2021SE
K151604	23ga Chandelier Illuminator, 25ga Chandelier IlluminatorMPA · Traditional	Peregrine Surgical , Ltd.	09/11/2015SE
K143123	Synergetics PHOTON EXMPA · Traditional	Synergetics	02/24/2015SE
K080067	Iscience Interventional Ophthalmic MicrocatheterMPA · Traditional	Iscience Interventional	07/18/2008SE
K062895	Xenon Brightstar Illumination System, Model 1266.XIIIMPA · Special	Dutch Ophthalmic Research Center International BV	10/13/2006SE
K062259	Iscience Surgical Fiberoptic Illuminator, Model Fi - 100MPA · Traditional	Iscience Surgical	08/15/2006SE

More from Iscience Surgical

510(k)	Device	Decision
K003036	Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional	12/22/2000SE
K000418	PDT Dosecalculator, Model 80000NDC · Traditional	10/24/2000SE
K000457	Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional	05/09/2000SE
K000420	Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003MRH · Traditional	05/08/2000SE

Questions and answers

When was Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001 cleared by the FDA?

Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001 (K000416) received a 510(k) decision of Substantially Equivalent on May 8, 2000, 90 days after the submission was received.

What is the product code of K000416?

The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.