Sawblade
FDA 510(k) K863788 · Tava Surgical Instruments
510(k) numberK863788
Submission
- Device name
- Sawblade
- Applicant
- Tava Surgical Instruments
Van Nuys, CA, US - Received
- September 26, 1986
- Decision date
- October 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFA – Blade, Saw, General & Plastic Surgery, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971978 | Graft Harvesting SawbladesGFA · Traditional | Wrightmedicaltechnologyinc | 06/18/1997SE |
| K954483 | Stryker Sagittal Saw AttachmentGFA · Traditional | Stryker Instruments | 01/30/1996SE |
| K955229 | Wright Medical Technology SawbladesGFA · Traditional | Wrightmedicaltechnologyinc | 01/18/1996SE |
| K953012 | Disposable & Reusable Surgical Cutting ToolsGFA · Traditional | Boston Surgical Products, Inc. | 07/12/1995SE |
| K950403 | Surgical Saw BladesGFA · Traditional | Transidyne General Corp. | 02/21/1995SE |
| K940501 | Re-Sharpenable Saw BladesGFA · Traditional | Adven Medical | 06/28/1994SE |
| K933595 | Bur, Surgical, General & Plastic SurgeryGFA · Traditional | Omega Surgical Instruments, Inc. | 03/16/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 3M Health Care, Sarns | 02/24/1994SE |
| K934603 | Surgical Saw BladesGFA · Traditional | American Medical Specialties, Inc. | 02/22/1994SE |
| K931769 | Snap Oscillating SawGFA · Traditional | Surgiquip, Inc. | 01/27/1994SE |
More from Surgiquip, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935367 | Tava Wire-DriverHSZ · Traditional | 04/21/1994SE |
| K940109 | Tava K-WireHTY · Traditional | 02/22/1994SE |
| K885273 | Micro Surgical Instrument SystemHSZ · Traditional | 01/30/1989SE |
| K884492 | Micro Surgical Instrument SystemHSZ · Traditional | 11/16/1988SE |
| K872475 | Surgical BurGFF · Traditional | 07/02/1987SE |
| K854543 | Pulse LavageFQH · Traditional | 01/27/1986SE |
Questions and answers
When was Sawblade cleared by the FDA?
Sawblade (K863788) received a 510(k) decision of Substantially Equivalent on October 14, 1986, 18 days after the submission was received.
What is the product code of K863788?
The FDA product code is GFA – Blade, Saw, General & Plastic Surgery, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4820.