Micro Rasps
FDA 510(k) K780771 · Amsco Co.
510(k) numberK780771
Submission
- Device name
- Micro Rasps
- Applicant
- Amsco Co.
Mchenry, IL, US - Received
- May 5, 1978
- Decision date
- May 16, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTR – Rasp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870349 | Biodynamics Femoral Canal Brush #1201HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K870333 | Biodynamics Small Joint Brush #1203HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K870329 | Acetabular Brush #1202 & Femoral Con. Brush #1202HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K813093 | Richards Acetabular BrushHTR · Traditional | Richard'S Medical Equip., Inc. | 11/20/1981SE |
| K812506 | The ArthrofileHTR · Traditional | Dyonics, Inc. | 09/24/1981SE |
| K771016 | Intermedullary BrushHTR · Traditional | Howmedica Corp. | 01/12/1978SE |
| K771745 | Rasps for Scraping BoneHTR · Traditional | Depuy, Inc. | 09/28/1977SE |
| K760109 | Prosthesis, Total Hip-RaspHTR · Traditional | Orthopedic Equipment Co., Inc. | 07/20/1976SE |
More from Orthopedic Equipment Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912471 | Eagle 3000 SDSFLE · Traditional | 06/26/1992SE |
| K854922 | Amsco Polaris SLFSY · Traditional | 01/24/1986SE |
| K833187 | Hall OsteonGET · Traditional | 10/31/1983SE |
| K832945 | Eagle 2000 Sterilizer Series Gas/AeraFLF · Traditional | 10/19/1983SE |
| K832188 | Hall ReciprocatorGET · Traditional | 08/12/1983SE |
| K832187 | Hall OscillatorGET · Traditional | 08/12/1983SE |
| K832186 | Hall Drill/ReamerGET · Traditional | 08/12/1983SE |
| K831086 | Ceiling Mounted SupportFQO · Traditional | 08/12/1983SE |
| K831309 | Delivery 4 TableKNC · Traditional | 06/15/1983SE |
| K823360 | Surgical LightFTD · Traditional | 12/03/1982SE |
Questions and answers
When was Micro Rasps cleared by the FDA?
Micro Rasps (K780771) received a 510(k) decision of Substantially Equivalent on May 16, 1978, 11 days after the submission was received.
What is the product code of K780771?
The FDA product code is HTR – Rasp, a Class I (low risk) device regulated under 21 CFR 878.4800.