GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
FDA 510(k) clearance K952586 · decided 1995-09-01
Clearance details
- K-number
- K952586
- Device name
- GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
- Applicant
- Gamp & Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-05
- Decision date
- 1995-09-01
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MPA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bridgeton, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) (K233653) | Peregrine Surgical, LLC | 2024-08-05 |
| ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (K221872) | Nova Eye Inc. (Business Name Nova Eye Medical) | 2023-03-30 |
| Nam illumination probe with chopper (K202670) | Oculight , Ltd. | 2021-08-20 |
| 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (K151604) | Peregrine Surgical , Ltd. | 2015-09-11 |
| Synergetics PHOTON EX (K143123) | Synergetics | 2015-02-24 |
| ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (K080067) | Iscience Interventional | 2008-07-18 |
| XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (K062895) | Dutch Ophthalmic Research Center International BV | 2006-10-13 |
| ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (K062259) | Iscience Surgical | 2006-08-15 |
| ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (K041108) | Iscience Surgical Corporation | 2004-06-22 |
| SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K032598) | Synergetics, Inc. | 2003-11-24 |
| INSIGHT 4000 ENDOSCOPE (K000252) | Insight Instruments Mfg., Inc. | 2000-10-17 |
Recalls involving this device
No recalls on record reference this clearance.