Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
FDA 510(k) K233653 · Peregrine Surgical, LLC
510(k) numberK233653
Submission
- Device name
- Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
- Applicant
- Peregrine Surgical, LLC
New Britain, PA, US - Received
- November 14, 2023
- Decision date
- August 5, 2024
- 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 |
| 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 |
| K041108 | Iscience Surgical Ophthalmic MicrocannulaMPA · Traditional | Iscience Surgical Corporation | 06/22/2004SE |
More from Iscience Surgical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorMPA · Traditional | 09/11/2015SE |
| K132614 | Peregrine Curved Illuminating Laser ProbeHQB · Special | 11/14/2013SE |
| K122997 | 23GA Curved Illuminating Laser ProbeHQB · Special | 06/26/2013SE |
| K122905 | Peregrine 23GA Curved Laser ProbeHQB · Special | 04/30/2013SE |
| K061024 | Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60HQF · Traditional | 06/21/2006SE |
| K031023 | Peregrine Illuminating Laser Probe Model PD600.10HQF · Traditional | 06/27/2003SE |
| K024061 | Peregrine Straight Laser Probe, Model PD6000.00GEX · Traditional | 03/07/2003SE |
| K990518 | Peregrine Wet Set, Model PD400.00FRN · Traditional | 03/25/1999SE |
| K981907 | V.F.I.-Viscous Fluid Infusion Tubing SetMRH · Traditional | 08/04/1998SE |
| K980797 | Peregrine Fiber Optic Multi-Function ManipulatorMPA · Traditional | 05/19/1998SE |
Questions and answers
When was Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) cleared by the FDA?
Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) (K233653) received a 510(k) decision of Substantially Equivalent on August 5, 2024, 265 days after the submission was received.
What is the product code of K233653?
The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.