Acufex T-Fix Delivery System
FDA 510(k) K942442 · Acufex Microsurgical, Inc.
510(k) numberK942442
Submission
- Device name
- Acufex T-Fix Delivery System
- Applicant
- Acufex Microsurgical, Inc.
Mansfield, MA, US - Received
- May 23, 1994
- Decision date
- December 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIA – Needle, Spinal, Short Term
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
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| K970997 | Neo-Care Lumber Puncture KitMIA · Traditional | Klein-Baker Medical, Inc. | 05/22/1997SE |
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More from Custom Medical Concepts, 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 T-Fix Delivery System cleared by the FDA?
Acufex T-Fix Delivery System (K942442) received a 510(k) decision of Substantially Equivalent on December 5, 1994, 196 days after the submission was received.
What is the product code of K942442?
The FDA product code is MIA – Needle, Spinal, Short Term, a Class II (moderate risk) device regulated under 21 CFR 868.5150.