Disposable Intra-Articular Blade
FDA 510(k) K830434 · Concept, Inc.
510(k) numberK830434
Submission
- Device name
- Disposable Intra-Articular Blade
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- February 9, 1983
- Decision date
- April 12, 1983
- 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 |
|---|---|---|
| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
| K912957 | Concept MicromillHRX · Traditional | 10/04/1991SE |
| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Disposable Intra-Articular Blade cleared by the FDA?
Disposable Intra-Articular Blade (K830434) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 62 days after the submission was received.
What is the product code of K830434?
The FDA product code is GFA – Blade, Saw, General & Plastic Surgery, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4820.