Product code NGY
- Device name
- Cannula, Trocar, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K012435 | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 | Bausch & Lomb, Inc. | 2001-10-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08052276019493 | Trocar 29G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019509 | Trocar 27G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019523 | Trocar set 27g with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019547 | Trocar 20g with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019561 | Trocar 23G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019585 | Trocar 25G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019608 | Trocar set 20G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019615 | Trocar set 23G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08052276019622 | Trocar set 25G with removable valve | AKTIVE SRL | 2023-06-12 |
| 08717872018904 | Disposable Hybrid Trocar System (23 gauge/ 0.6 mm) (27 gauge/ 0.4mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-11 |
| 08717872004099 | One step stiletto insertor.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-09 |
| 08717872020754 | Universal silicone infusion line for 25 gauge / 0.5 mm cannula system | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872020334 | Disposable one step single cannula including inserter. (23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872020327 | Disposable one step single cannula including inserter. (25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872020310 | Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872025711 | Disposable heavy silicon extraction cannula 23G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872017372 | Disposable One Step Cannula System (25 gauge/0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872017099 | Disposable Two step Vitrectomy System.(20 gauge / 0.9 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872016948 | Disposable One step Cannula System.(27 gauge / 0.4 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872002521 | Closure valves for 23 gauge/0.6 mm vitrectomy system. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872015255 | Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872003221 | Universal silicone infusion line for 20 gauge/0.9 mm cannula system. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872003214 | Disposable Universal silicone infusion line for 23 gauge / 0.6 mm cannula system | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872002675 | Korobelnik self-retaining infusion cannula, 5.0 mm. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872002446 | Disposable One step Cannula System.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872002439 | Disposable Two step vitrectomy system. (23 gauge/ 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872002323 | Closure valves for 20 gauge/0.9 mm cannula system. | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 08717872002309 | Reusable universal cannula.(20 gauge / 0.9 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2021-02-01 |
| 07612717069190 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2020-08-19 |
| 07612717069275 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2020-08-19 |