510(k) K973293
- Device
- SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
- Applicant
- VAUGHAN WEEKS
- 510(k) number
- K973293
- Product code
- MPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-18
- Date received
- 1997-09-02
- Regulation
- 876.1500
- Classification name
- Endoilluminator
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VAUGHAN WEEKS
- Address
- 7346 W. River Rd. Caledonia WI US 53108 53108
FDA Registration Numbers#
- 2529392
- 3004467263
- 3016678045
- 1644019
- 2029275
- 3010208880
- 3019810045
- 1920664
- 2246552
- 3012037425
- 3002808022
- 1313525
- 3013002167
- 2939653
- 9611516
- 3007589150
- 2953359
- 1932402
- 3005941719
- 8040619
- 3009337401
- 2523835
- 3002991496
- 3005641545
- 1928237
- 9615745
- 3005012805
- 1650907
Source Documents#
Other 510(k) Records For Product Code MPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories, Inc. | 2024-12-04 |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | Peregrine Surgical, LLC | 2024-08-05 |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | Nova Eye Inc. (Business Name Nova Eye Medical) | 2023-03-30 |
| K202670 | Nam illumination probe with chopper | Oculight , Ltd. | 2021-08-20 |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical , Ltd. | 2015-09-11 |
| K143123 | Synergetics PHOTON EX | Synergetics | 2015-02-24 |
| K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER | Iscience Interventional | 2008-07-18 |
| K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | Dutch Ophthalmic Research Center International BV | 2006-10-13 |
| K062259 | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 | Iscience Surgical | 2006-08-15 |
| K041108 | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA | Iscience Surgical Corporation | 2004-06-22 |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Synergetics, Inc. | 2003-11-24 |
| K000252 | INSIGHT 4000 ENDOSCOPE | Insight Instruments Mfg., Inc. | 2000-10-17 |
| K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | Retinalabs.Com | 2000-05-08 |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | Peregrine Surgical , Ltd. | 1998-05-19 |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | Peregrine Surgical , Ltd. | 1998-05-12 |
Legacy Summary#
summary
FDA Review#
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