Panels › Gastroenterology, Urology › Product code MPA · Class 2
Endoilluminator
Regulation 876.1500
1510(k)s in 12 months (41 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in MPA
| Company | 510(k)s | Recalls |
|---|---|---|
| Peregrine Surgical , Ltd. | 6 | 0 |
| Gamp & Assoc. | 5 | 0 |
| American Medical Devices, Inc. | 3 | 0 |
| M.B. Industries, Inc. | 3 | 0 |
| Synergetics | 3 | 0 |
| Dutch Ophthalmic USA, Inc. | 2 | 0 |
| Iscience Surgical | 2 | 0 |
| Vaughan Weeks | 2 | 0 |
| Alcon Laboratories, Inc. | 1 | 0 |
| Alcon Research LLC | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) Nova Eye, Inc. | MPA |
| Dec 4, 2024 | K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator ( Alcon Laboratories, Inc. | MPA |
| Aug 5, 2024 | K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-0 Peregrine Surgical, LLC | MPA |
| Mar 30, 2023 | K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System Nova Eye Inc. (Business Name Nova Eye Medical) | MPA |
| Aug 20, 2021 | K202670 | Nam illumination probe with chopper Oculight , Ltd., KR | MPA |
| Sep 11, 2015 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator Peregrine Surgical , Ltd. | MPA |
| Feb 24, 2015 | K143123 | Synergetics PHOTON EX Synergetics | MPA |
| Jul 18, 2008 | K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER Iscience Interventional | MPA |
| Oct 13, 2006 | K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII Dutch Ophthalmic Research Center International BV | MPA |
| Aug 15, 2006 | K062259 | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 Iscience Surgical | MPA |
| Jun 22, 2004 | K041108 | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA Iscience Surgical Corporation | MPA |
| Nov 24, 2003 | K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE Synergetics, Inc. | MPA |
| Oct 17, 2000 | K000252 | INSIGHT 4000 ENDOSCOPE Insight Instruments Mfg., Inc. | MPA |
| May 8, 2000 | K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 Retinalabs.Com | MPA |
| May 19, 1998 | K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR Peregrine Surgical , Ltd. | MPA |
| May 12, 1998 | K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 Peregrine Surgical , Ltd. | MPA |
| Mar 31, 1998 | K980027 | PEREGRINE SHIELDED DIFFUSION PROBE Peregrine Surgical , Ltd. | MPA |
| Mar 31, 1998 | K980025 | PEREGRINE TAPERED DIFFUSION PROBE Peregrine Surgical , Ltd. | MPA |
| Nov 25, 1997 | K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM Dutch Ophthalmic USA, Inc. | MPA |
| Nov 18, 1997 | K973293 | SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR Vaughan Weeks | MPA |
| Nov 14, 1997 | K973290 | SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK Vaughan Weeks | MPA |
| Nov 7, 1997 | K973757 | D.O.R.C. SOLUX LIGHT SOURCE Dutch Ophthalmic USA, Inc. | MPA |
| Jun 25, 1997 | K971679 | I-SCOPE OPHTHALMIC ENDOSCOPE Ophthalmic Technologies, Inc., CA | MPA |
| Jun 24, 1997 | K970882 | ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) American Medical Devices, Inc. | MPA |
| Jun 9, 1997 | K964005 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE Synergetics, Inc. | MPA |
| May 20, 1997 | K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) American Medical Devices, Inc. | MPA |
| May 13, 1997 | K964553 | MBI CO-AXIAL ILLUMINATED RETINAL PICK M.B. Industries, Inc. | MPA |
| May 13, 1997 | K964405 | MBI ILLUMINATED RETINAL PICK M.B. Industries, Inc. | MPA |
| May 6, 1997 | K971338 | SYNTEC, INC. DISPOSABLE BARE END FIBER Syntec, Inc. | MPA |
| May 6, 1997 | K970878 | ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT American Medical Devices, Inc. | MPA |
| Mar 31, 1997 | K964555 | VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) Vitrotec, Inc. | MPA |
| Dec 20, 1996 | K963417 | VITLITE (TR7700) Escalon Trek Medical | MPA |
| Jul 15, 1996 | K961036 | MBI FIBEROPTIC ENDO-ILLUMINATOR M.B. Industries, Inc. | MPA |
| Mar 26, 1996 | K960007 | STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR Storz | MPA |
| Jan 5, 1996 | K952585 | GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR Gamp & Assoc. | MPA |
| Jan 5, 1996 | K952581 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR Gamp & Assoc. | MPA |
| Oct 19, 1995 | K951627 | INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM Infinitech, Inc. | MPA |
| Oct 2, 1995 | K946136 | INFINITECH LIGHTED INFUSION CANNULA Surgical Technologies, Inc. | MPA |
| Sep 1, 1995 | K952586 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR Gamp & Assoc. | MPA |
| Sep 1, 1995 | K952584 | GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK Gamp & Assoc. | MPA |
| Sep 1, 1995 | K952580 | GAMP & ASSOCIATES DISPOSABLE BARE END FIBER Gamp & Assoc. | MPA |
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