Myocur Blade Pac
FDA 510(k) K822392 · Myocure, Inc.
510(k) numberK822392
Submission
- Device name
- Myocur Blade Pac
- Applicant
- Myocure, Inc.
Walker, MI, US - Received
- August 9, 1982
- Decision date
- August 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMN – Suture, Nonabsorable, Ophthalmic
- Device class
- Class III (high risk)
- Implant
- Yes
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 |
| K863666 | The Saver Kit · Traditional | 10/20/1986SE |
| K863663 | Ophthalmic Surgical Ocular MarkersHMR · Traditional | 10/20/1986SE |
| K863662 | Ophthalmic Surgical Drape · Traditional | 10/20/1986SE |
Questions and answers
When was Myocur Blade Pac cleared by the FDA?
Myocur Blade Pac (K822392) received a 510(k) decision of Substantially Equivalent on August 25, 1982, 16 days after the submission was received.
What is the product code of K822392?
The FDA product code is HMN – Suture, Nonabsorable, Ophthalmic, a Class III (high risk) device.