Surgifresh Surgical Smoke Removal
FDA 510(k) K870932 · Texas Medical Products, Inc.
510(k) numberK870932
Submission
- Device name
- Surgifresh Surgical Smoke Removal
- Applicant
- Texas Medical Products, Inc.
Houston, TX, US - Received
- March 9, 1987
- Decision date
- March 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Texas Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893417 | Surgifresh Sub-Micron Mask No. 901008-000FXX · Traditional | 06/22/1989SE |
| K851575 | Dr. Bruno Lnage Mini Photometer · Traditional | 10/18/1985SE |
| K830634 | Cardiotomy FilterJOD · Traditional | 06/30/1983SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | 01/12/1982SE |
| K810532 | Disposable StopcockDTZ · Traditional | 04/23/1981SE |
| K810515 | Disposable 2-STAGE CannulaDWF · Traditional | 04/23/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | 03/05/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | 01/16/1981SE |
| K802544 | Disposable Quick Release Perfusion AdapDTL · Traditional | 01/16/1981SE |
| K802543 | Ridgid Vena Cava CannulaeDWF · Traditional | 01/16/1981SE |
Questions and answers
When was Surgifresh Surgical Smoke Removal cleared by the FDA?
Surgifresh Surgical Smoke Removal (K870932) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 22 days after the submission was received.