Acro-Poly, Inc. Handpiece/Anglehead Accessories for Surgical Instuments
FDA 510(k) K934172 · Acro-Poly, Inc.
510(k) numberK934172
Submission
- Device name
- Acro-Poly, Inc. Handpiece/Anglehead Accessories for Surgical Instuments
- Applicant
- Acro-Poly, Inc.
Riverside, CA, US - Received
- August 27, 1993
- Decision date
- October 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K012738 | Symphony Graft Delivery System (GDS)GEY · Traditional | Depuyacromed | 11/14/2001SE |
| K972308 | Mednext 1000 DrillGEY · Traditional | Mednext, Inc. | 08/20/1997SE |
| K971941 | Aqua SprayGEY · Traditional | Boyd Industries, Inc. | 08/14/1997SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
Questions and answers
When was Acro-Poly, Inc. Handpiece/Anglehead Accessories for Surgical Instuments cleared by the FDA?
Acro-Poly, Inc. Handpiece/Anglehead Accessories for Surgical Instuments (K934172) received a 510(k) decision of Substantially Equivalent on October 27, 1993, 61 days after the submission was received.
What is the product code of K934172?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.