Acufex Microsurgical, Inc.
Medical device manufacturer in Mansfield, MA.
78510(k) clearances
0PMA approvals
0recalls
Device types
- HRX Arthroscope 26
- JDR Staple, Fixation, Bone 9
- HWC Screw, Fixation, Bone 6
- KGS Retention Device, Suture 4
- GCJ Laparoscope, General & Plastic Surgery 3
- HTY Pin, Fixation, Smooth 2
- FZX Guide, Surgical, Instrument 2
- LXH Orthopedic Manual Surgical Instrument 2
- HWQ Passer 2
- HSZ Instrument, Surgical, Orthopedic, Pneumatic… 2
- HTJ Gauge, Depth 2
- GAE Snare, Surgical 2
- LZC Medical Glove, Specialty 2
- GAT Suture, Nonabsorbable, Synthetic… 1
- HTD Forceps 1
- EBG Crown And Bridge, Temporary, Resin 1
- HRS Plate, Fixation, Bone 1
- HJB Instrument, Measuring, Corneal Radius 1
- HST Apparatus, Traction, Non-Powered 1
- FWZ Operating Room Accessories Table Tray 1
510(k) clearances
| 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 |
| K941709 | Acufex Arthroscopic Discectomy SystemsHRX · Traditional | 04/14/1995SE |
| K943548 | Bioabsorbable Interference ScrewJDR · Traditional | 03/20/1995SE |
| K934867 | Acufex Tag AnchorJDR · Traditional | 02/09/1995SE |
| K942442 | Acufex T-Fix Delivery SystemMIA · Traditional | 12/05/1994SE |
| K942846 | Acufex(R) Endo-Femoral AimerHRX · Traditional | 09/28/1994SE |
| K942834 | Acufex Uni-Cut 4. Omm Carpal Tunnel CannulaHRX · Traditional | 09/28/1994SE |
| K942574 | Grasper, Dissector, Forceps, Needle HolderGCJ · Traditional | 09/28/1994SE |
| K942079 | Manual Surgical InstrumentsHRX · Traditional | 09/28/1994SE |
| K940290 | Acufex Acl Sheath for Interference ScrewsHRX · Traditional | 09/28/1994SE |
| K933948 | Acufex Endobutton SystemMAI · Traditional | 07/21/1994SE |
| K932090 | Acufex Disposable Meniscal CannulaHRX · Traditional | 06/28/1994SE |
| K931836 | Acufex Smooth and Threaded PinsHTY · Traditional | 06/28/1994SE |
| K931519 | Acufex SuretacJDR · Traditional | 06/16/1994SE |
| K941364 | Acufex T-Fix Rotator Cuff Guide SystemsHRX · Traditional | 05/16/1994SE |
| K940985 | Acufex(R) Arthroplasty InstrumentsHRX · Traditional | 05/16/1994SE |
| K940981 | Acufex Linear/Rotary InstrumentsHRX · Traditional | 05/16/1994SE |
| K940481 | Acufex Arthroscopic Shoulder Guide SystemHRX · Traditional | 05/06/1994SE |
| K940623 | Acufex Suretac Ixc SystemsHRX · Traditional | 04/26/1994SE |
| K940506 | Acufex Arthroscopic Suture CutterHRX · Traditional | 04/26/1994SE |
| K940241 | Acufex Video SystemGCJ · Traditional | 04/12/1994SE |
| K940480 | Acufex Sub-Acromial Space Measuring DeviceHTJ · Traditional | 03/23/1994SE |
| K934181 | Acufex Adjustable-Length CannulaHRX · Traditional | 03/23/1994SE |
| K932460 | Acufex Meniscal RaspsHRX · Traditional | 03/22/1994SE |
| K932718 | Acufex Metal Acl CannulaHRX · Traditional | 03/21/1994SE |
| K934270 | Acufex ArthroscopeHRX · Traditional | 02/14/1994SE |
| K933921 | Acuflex Disposable KnivesHTS · Traditional | 01/26/1994SE |
| K931621 | Acufex Pro-Pac and Iso-PacHRX · Traditional | 01/21/1994SE |
| K931837 | Acufex Sterile DrillsHWE · Traditional | 01/07/1994SE |
| K930538 | Acufex Suretac(R) PacJDR · Traditional | 09/13/1993SE |
| K921481 | Interference-Cannu-Flex/Silk Screws-Screw Dr/G WirHWC · Traditional | 08/24/1993SE |
| K911293 | Acufex(R) Tag(Tm)JDR · Traditional | 07/21/1993SE |
| K922766 | Acufex Biofix Absorbable Fixation Rod-ModificationHTY · Traditional | 07/09/1993SESK |
| K920620 | Fluoro-Shield Radiation Reduction GlovesLZC · Traditional | 06/22/1993SE |
| K926036 | Acufex Suture RetrieverGAE · Traditional | 05/05/1993SE |
| K925573 | Acufex T-BarHRX · Traditional | 05/05/1993SE |
| K923381 | Soft Tissue ExpanderHWQ · Traditional | 05/05/1993SE |
| K920621 | Acufex Passing Pins and Surgical WireHWQ · Traditional | 05/05/1993SE |
| K925335 | Acufex Intra Articular Measuring DeviceHTJ · Traditional | 12/29/1992SE |
| K922559 | Acufex Endofix ButtonEBG · Traditional | 12/24/1992SE |
| K924514 | Acufex Fixation PostHWC · Traditional | 10/13/1992SE |
| K922557 | Acufex Arthroscopic Carpal Tunnel Release KitHRX · Traditional | 09/17/1992SE |
| K920454 | Cleartrac CannulaHRX · Traditional | 09/16/1992SE |
| K911837 | Suretac Polyglyconate Absorbable Fixation DeviceJDR · Traditional | 11/15/1991SE |
| K902001 | Surgical Retention BarKGS · Traditional | 05/09/1990SE |
| K900132 | Acufex Sterile Cannulated Interference Screw;HWC · Traditional | 03/28/1990SE |
| K893093 | Flouroshield Radiation Reduction GloveLZC · Traditional | 02/13/1990SE |
| K895711 | Acufex Interference Screw, SterileHWC · Traditional | 01/09/1990SE |
| K896310 | Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional | 11/20/1989SE |
| K890641 | Acufex Cannulated Screws, Washers, Bone PlatesHRS · Traditional | 02/27/1989SE |
| K884565 | Acufex Fixation ButtonKGS · Traditional | 02/27/1989SE |
| K883910 | Acufex Interference Screw and ScrewdriverHWC · Traditional | 10/12/1988SE |
| K881224 | Acufex Suture Retriever, Sterile DisposableGAE · Traditional | 06/01/1988SE |
| K880881 | Artus Disposable Sheaths/CuttersHSZ · Traditional | 05/04/1988SE |
| K852424 | Acufex Comparative Surgical KeratometerHJB · Traditional | 09/11/1985SE |
| K844130 | Acufex Arthroscopic ShaverHSZ · Traditional | 03/21/1985SE |
| K843208 | Acufex ArthroscopeHRX · Traditional | 09/11/1984SE |
| K841388 | Acufex Shoulder HolderHST · Traditional | 05/16/1984SE |
| K834350 | Acufex Drez Communicating Drill GuideFZX · Traditional | 03/19/1984SE |
| K834370 | Mulhollan Arthroscopic Needle CarrierLXH · Traditional | 02/27/1984SE |
| K834369 | Crane Meniscal Suture SetLXH · Traditional | 02/27/1984SE |
| K832277 | Acuflex Levy Acl Drill Guide SysHRX · Traditional | 08/16/1983SE |
| K831218 | Arthroscopy Infusion Sys..ValveHRX · Traditional | 07/18/1983SE |
| K830720 | Graf Meniscal Suture SetFZX · Traditional | 06/16/1983SE |
| K830719 | Universal CannulaGCJ · Traditional | 06/16/1983SE |
| K830707 | Acufex Universal Leg HolderFWZ · Traditional | 05/02/1983SE |
| K822439 | Acufex Magnetic Retriever · Traditional | 10/13/1982SE |
| K800274 | Acufex ProbesHXB · Traditional | 02/19/1980SE |
| K800273 | Acufex ForcepsHTD · Traditional | 02/19/1980SE |