Acufex Forceps
FDA 510(k) K800273 · Acufex Microsurgical, Inc.
510(k) numberK800273
Submission
- Device name
- Acufex Forceps
- 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
- HTD – Forceps
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051281 | The Needle CatcherHTD · Traditional | E.D.Medical , Ltd. | 09/08/2005SE |
| K974595 | Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974594 | Semkin Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974593 | Semkin Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | Marlo Surgical Technology | 10/23/1991SE |
| K911180 | Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K895212 | Tik ExtraktorHTD · Traditional | Instruments of Sweden, Inc. | 09/27/1989SE |
| K890373 | Hemorrhoidal ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890369 | Gall Stone ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890263 | Cilia ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
More from Kinetic Medical Products
| 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 Forceps cleared by the FDA?
Acufex Forceps (K800273) 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 K800273?
The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.