Acufex Passing Pins and Surgical Wire
FDA 510(k) K920621 · Acufex Microsurgical, Inc.
510(k) numberK920621
Submission
- Device name
- Acufex Passing Pins and Surgical Wire
- Applicant
- Acufex Microsurgical, Inc.
Great Neck, NY, US - Received
- February 11, 1992
- Decision date
- May 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWQ – Passer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970360 | Mitek Suture RetrograderHWQ · Traditional | Mitek Products | 03/10/1997SE |
| K923381 | Soft Tissue ExpanderHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K885311 | Meniscus Mender II LoopHWQ · Traditional | Instrument Makar, Inc. | 02/09/1989SE |
| K843592 | Vico Micro Surgical InstrumentsHWQ · Traditional | Visitec Co. | 10/05/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841622 | Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | Dow Corning Corp. Healthcare Industries Materials | 07/10/1981SE |
| K791960 | Roth-Kennedy PasserHWQ · Traditional | 3M Company | 10/04/1979SE |
More from 3M Company
| 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 Passing Pins and Surgical Wire cleared by the FDA?
Acufex Passing Pins and Surgical Wire (K920621) received a 510(k) decision of Substantially Equivalent on May 5, 1993, 449 days after the submission was received.
What is the product code of K920621?
The FDA product code is HWQ – Passer, a Class I (low risk) device regulated under 21 CFR 888.4540.