Iscience Interventional Ophthalmic Microcatheter
FDA 510(k) K080067 · Iscience Interventional
510(k) numberK080067
Submission
- Device name
- Iscience Interventional Ophthalmic Microcatheter
- Applicant
- Iscience Interventional
Menlo Park, CA, US - Received
- January 10, 2008
- Decision date
- July 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)MPA · Traditional | Nova Eye, Inc. | 08/10/2026SE |
| 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 |
| 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 |
| K041108 | Iscience Surgical Ophthalmic MicrocannulaMPA · Traditional | Iscience Surgical Corporation | 06/22/2004SE |
Questions and answers
When was Iscience Interventional Ophthalmic Microcatheter cleared by the FDA?
Iscience Interventional Ophthalmic Microcatheter (K080067) received a 510(k) decision of Substantially Equivalent on July 18, 2008, 190 days after the submission was received.
What is the product code of K080067?
The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.