Acuflex Disposable Knives
FDA 510(k) K933921 · Acufex Microsurgical, Inc.
510(k) numberK933921
Submission
- Device name
- Acuflex Disposable Knives
- Applicant
- Acufex Microsurgical, Inc.
Mansfield, MA, US - Received
- August 10, 1993
- Decision date
- January 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HTS – Knife, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | Associated Medical Products Co. | 02/22/1994SE |
| K882525 | Spinal MicroknifeHTS · Traditional | Karlin Technology, Inc. | 09/22/1988SE |
| K873714 | Banana Knife, Disposable #TM-1612HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873713 | Triangular Knife, Disposable #TM-1611HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873711 | Retrograde Knife, Disposable #TM-1613HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873712 | Standard Knife, Disposable #TM-1610HTS · Traditional | Arthropedics, Inc. | 10/15/1987SE |
| K842820 | Arthroscopy KnivesHTS · Traditional | Medtech Industries, Inc. | 08/14/1984SE |
| K771851 | Arthroscope Operative Knife SetHTS · Traditional | Richard Wolf Medical Instruments Corp. | 10/27/1977SE |
More from Richard Wolf Medical Instruments Corp.
| 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 Acuflex Disposable Knives cleared by the FDA?
Acuflex Disposable Knives (K933921) received a 510(k) decision of Substantially Equivalent on January 26, 1994, 169 days after the submission was received.
What is the product code of K933921?
The FDA product code is HTS – Knife, Orthopedic, a Class I (low risk) device regulated under 21 CFR 888.4540.