MPA — Endoilluminator Class II
FDA product code MPA covers "Endoilluminator", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MPA
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242184 | alcon laboratories | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 | December 4, 2024 |
| K233653 | peregrine surgical | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00) | August 5, 2024 |
| K221872 | nova eye inc. (business name nova eye medical) | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | March 30, 2023 |
| K202670 | oculight | Nam illumination probe with chopper | August 20, 2021 |
| K151604 | peregrine surgical | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | September 11, 2015 |
| K143123 | synergetics | Synergetics PHOTON EX | February 24, 2015 |
| K080067 | iscience interventional | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER | July 18, 2008 |
| K062895 | dutch ophthalmic research center international | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | October 13, 2006 |
| K062259 | iscience surgical | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 | August 15, 2006 |
| K041108 | iscience surgical corporation | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA | June 22, 2004 |
| K032598 | synergetics | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | November 24, 2003 |
| K000252 | insight instruments mfg | INSIGHT 4000 ENDOSCOPE | October 17, 2000 |
| K000416 | retinalabs.com | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | May 8, 2000 |
| K980797 | peregrine surgical | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | May 19, 1998 |
| K980530 | peregrine surgical | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND | May 12, 1998 |
| K980027 | peregrine surgical | PEREGRINE SHIELDED DIFFUSION PROBE | March 31, 1998 |
| K980025 | peregrine surgical | PEREGRINE TAPERED DIFFUSION PROBE | March 31, 1998 |
| K973229 | dutch ophthalmic usa | D.O.R.C. HEXON ILLUMINATION SYSTEM | November 25, 1997 |
| K973293 | vaughan weeks | SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR | November 18, 1997 |
| K973290 | vaughan weeks | SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK | November 14, 1997 |