Acufex Probes
FDA 510(k) K800274 · Acufex Microsurgical, Inc.
510(k) numberK800274
Submission
- Device name
- Acufex Probes
- Applicant
- Acufex Microsurgical, Inc.
Mchenry, IL, US - Received
- February 7, 1980
- Decision date
- February 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXB – Probe
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960539 | Diao Hand Surgery SetHXB · Traditional | Kinetikos Medical, Inc. | 07/23/1996SE |
| K943472 | Cohort Avb Retractor SystemHXB · Traditional | Cohort Medical Products Group, Inc. | 10/20/1994SE |
| K912843 | Flexmedics Retract Orth Probe, Pettine Bone ProbeHXB · Traditional | Flexmedics | 09/24/1991SE |
| K890227 | Surgical ProbeHXB · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K873652 | Hook Probe #TM-1376HXB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873651 | Blunt Measuring Probe W/2MM Gradations #TM-1375HXB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K863149 | Bowen ProbeHXB · Traditional | Bowen & Company, Inc. | 09/05/1986SE |
| K841971 | 2.5MM & 4MM Probe K841969-LABELINGHXB · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K840558 | Shutt Precision ProbesHXB · Traditional | Concept, Inc. | 04/25/1984SE |
| K810294 | Line CaddyHXB · Traditional | Instranetics, Inc. | 02/26/1981SE |
More from Instranetics, 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 Probes cleared by the FDA?
Acufex Probes (K800274) received a 510(k) decision of Substantially Equivalent on February 19, 1980, 12 days after the submission was received.
What is the product code of K800274?
The FDA product code is HXB – Probe, a Class I (low risk) device regulated under 21 CFR 888.4540.