Bone Pad Remover
FDA 510(k) K910225 · Acra Cut, Inc.
510(k) numberK910225
Submission
- Device name
- Bone Pad Remover
- Applicant
- Acra Cut, Inc.
Acton, MA, US - Received
- January 18, 1991
- Decision date
- February 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K220920 | Matreneu Percutaneous Balloon Compression KitHAO · Traditional | Shenzhen Shineyard Medical Device Co. , Ltd. | 09/07/2022SE |
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| K951492 | Rib ResectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 05/18/1995SE |
| K943115 | Auto Suture Pituitary Spinal RongeurHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/25/1994SE |
| K942971 | Auto Suture Spinal DissectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942970 | Auto Suture Spinal ElevatorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942969 | Auto Suture Spinal Nerve HookHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942968 | Auto Suture Spinal OsteotomeHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942967 | Auto Suture Spinal CuretteHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K923723 | Silicone Brain Spatula SetHAO · Traditional | Redmond Neurosurgical, Inc. | 08/12/1992SE |
More from Redmond Neurosurgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032970 | Acra-Cut Xpress 120HBF · Traditional | 12/08/2003SE |
| K944311 | Acra-CutHBO · Traditional | 11/18/1994SE |
| K911819 | Acra-Cut Neurological Surgical Device-PoweredHBE · Traditional | 09/10/1991SE |
| K911812 | Acra-Cut Wire Pass DrillHBE · Traditional | 09/10/1991SE |
| K910226 | Dural DissectorsHAO · Traditional | 02/12/1991SE |
| K892866 | Automatic Cranial Drill (Perforator)HBF · Traditional | 06/15/1989SE |
| K833266 | Acra-CutHBF · Traditional | 12/29/1983SE |
Questions and answers
When was Bone Pad Remover cleared by the FDA?
Bone Pad Remover (K910225) received a 510(k) decision of Substantially Equivalent on February 12, 1991, 25 days after the submission was received.
What is the product code of K910225?
The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.