Acufex Arthroscopic Shaver
FDA 510(k) K844130 · Acufex Microsurgical, Inc.
510(k) numberK844130
Submission
- Device name
- Acufex Arthroscopic Shaver
- Applicant
- Acufex Microsurgical, Inc.
Norwood, MA, US - Received
- October 23, 1984
- Decision date
- March 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K972860 | Curvtek TSR SystemHSZ · Traditional | Biolectron, Inc. | 10/31/1997SE |
| K970345 | Alignment InstrumentHSZ · Traditional | Richard Wolf Medical Instruments Corp. | 04/29/1997SE |
| K955084 | Aspach 65,000 (Modification)HSZ · Traditional | The Anspach Effort, Inc. | 01/17/1996SE |
| K954080 | Sodem High Speed SystemHSZ · Traditional | Sodem Diffusion SA | 10/16/1995SE |
| K944590 | Ethicon Drill Bit and Drill GuideHSZ · Traditional | ETHICON, Inc. | 05/11/1995SE |
| K934336 | SpinalplaneHSZ · Traditional | Synvasive Technology, Inc. | 03/10/1995SN |
| K940276 | Filter, DiffuserHSZ · Traditional | Anspach Mfg., Inc. | 11/16/1994SE |
| K942760 | Pneumatic Wire TensionerHSZ · Traditional | Smith & Nephew Richards, Inc. | 09/06/1994SE |
| K941681 | Arthrex Circular Harvesting SawHSZ · Traditional | Arthrex, Inc. | 08/25/1994SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961555 | Acufex Tag Bioabsorbable AnchorsJDR · Traditional | 07/10/1996SE |
| K961853 | Proline Fast Pass Arthoscopic Needle PasserHRX · Traditional | 06/21/1996SE |
| K954246 | Acufex Endofix Absorbable Interference ScrewHWC · Traditional | 02/15/1996SN |
| K952535 | Acufex Endobutton TapeGAT · Traditional | 02/08/1996SN |
| K953276 | Acufex Tag Delivery SystemJDR · Traditional | 10/05/1995SE |
| K953459 | Acufex Tag AnchorMBI · Traditional | 08/23/1995SE |
| K941740 | Acufex Rotator Cuff Fixation ButtonKGS · Traditional | 06/30/1995SE |
| K944500 | Acufex Patellar Bone Block SizerHRX · Traditional | 06/12/1995SE |
| K951859 | Acufex Endobutton PackHRX · Traditional | 06/09/1995SE |
| K946346 | Acufex Tag(R) Bioabsorbable AnchorsJDR · Traditional | 04/26/1995SE |
Questions and answers
When was Acufex Arthroscopic Shaver cleared by the FDA?
Acufex Arthroscopic Shaver (K844130) received a 510(k) decision of Substantially Equivalent on March 21, 1985, 149 days after the submission was received.
What is the product code of K844130?
The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.