The Saver Kit
FDA 510(k) K863666 · Myocure, Inc.
510(k) numberK863666
Submission
- Device name
- The Saver Kit
- Applicant
- Myocure, Inc.
Glendale, CA, US - Received
- September 18, 1986
- Decision date
- October 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Myocure, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880347 | Anesthesia/Retrobulbar NeedlesHMX · Traditional | 05/03/1988SE |
| K880346 | CannulasHMX · Traditional | 05/03/1988SE |
| K880345 | Cystotomes/KnifesHNY · Traditional | 05/03/1988SE |
| K874057 | Ophthalmic Tip & Blade ScalpelsHNN · Traditional | 12/23/1987SE |
| K874056 | Ophthalmic Disposable BladesHNN · Traditional | 12/22/1987SE |
| K873385 | Ophthalmic Phaco-BladeHNN · Traditional | 09/21/1987SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | 11/17/1986SE |
| K863663 | Ophthalmic Surgical Ocular MarkersHMR · Traditional | 10/20/1986SE |
| K863662 | Ophthalmic Surgical Drape · Traditional | 10/20/1986SE |
| K863665 | The UltimateHNN · Traditional | 09/25/1986SE |
Questions and answers
When was The Saver Kit cleared by the FDA?
The Saver Kit (K863666) received a 510(k) decision of Substantially Equivalent on October 20, 1986, 32 days after the submission was received.