Anadias Nasal Saw Blades
FDA 510(k) K854192 · Anadias, Inc.
510(k) numberK854192
Submission
- Device name
- Anadias Nasal Saw Blades
- Applicant
- Anadias, Inc.
Belleville, NJ, US - Received
- October 15, 1985
- Decision date
- November 13, 1985
- 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 |
|---|---|---|
| K871190 | Anadias Zara System Malar ImplantsFWP · Traditional | 04/10/1987SE |
Questions and answers
When was Anadias Nasal Saw Blades cleared by the FDA?
Anadias Nasal Saw Blades (K854192) received a 510(k) decision of Substantially Equivalent on November 13, 1985, 29 days after the submission was received.
What is the product code of K854192?
The FDA product code is GFA – Blade, Saw, General & Plastic Surgery, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4820.