Company ยท US
Acufex Microsurgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1996. Name variants (Inc, Corp, punctuation) are merged.
78510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 26 |
| JDR | Staple, Fixation, Bone | 9 |
| HWC | Screw, Fixation, Bone | 6 |
| KGS | Retention Device, Suture | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 |
| FZX | Guide, Surgical, Instrument | 2 |
| GAE | Snare, Surgical | 2 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 2 |
| HTJ | Gauge, Depth | 2 |
| HTY | Pin, Fixation, Smooth | 2 |
| HWQ | Passer | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 2 |
| LZC | Medical Glove, Specialty | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
| HJB | Instrument, Measuring, Corneal Radius | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HST | Apparatus, Traction, Non-Powered | 1 |
| HTD | Forceps | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 1996 | K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS Acufex Microsurgical, Inc. | JDR |
| Jun 21, 1996 | K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER Acufex Microsurgical, Inc. | HRX |
| Feb 15, 1996 | K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW Acufex Microsurgical, Inc. | HWC |
| Feb 8, 1996 | K952535 | ACUFEX ENDOBUTTON TAPE Acufex Microsurgical, Inc. | GAT |
| Oct 5, 1995 | K953276 | ACUFEX TAG DELIVERY SYSTEM Acufex Microsurgical, Inc. | JDR |
| Aug 23, 1995 | K953459 | ACUFEX TAG ANCHOR Acufex Microsurgical, Inc. | MBI |
| Jun 30, 1995 | K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON Acufex Microsurgical, Inc. | KGS |
| Jun 12, 1995 | K944500 | ACUFEX PATELLAR BONE BLOCK SIZER Acufex Microsurgical, Inc. | HRX |
| Jun 9, 1995 | K951859 | ACUFEX ENDOBUTTON PACK Acufex Microsurgical, Inc. | HRX |
| Apr 26, 1995 | K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS Acufex Microsurgical, Inc. | JDR |
| Apr 14, 1995 | K941709 | ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS Acufex Microsurgical, Inc. | HRX |
| Mar 20, 1995 | K943548 | BIOABSORBABLE INTERFERENCE SCREW Acufex Microsurgical, Inc. | JDR |
| Feb 9, 1995 | K934867 | ACUFEX TAG ANCHOR Acufex Microsurgical, Inc. | JDR |
| Dec 5, 1994 | K942442 | ACUFEX T-FIX DELIVERY SYSTEM Acufex Microsurgical, Inc. | MIA |
| Sep 28, 1994 | K942846 | ACUFEX(R) ENDO-FEMORAL AIMER Acufex Microsurgical, Inc. | HRX |
| Sep 28, 1994 | K942834 | ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA Acufex Microsurgical, Inc. | HRX |
| Sep 28, 1994 | K942574 | GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER Acufex Microsurgical, Inc. | GCJ |
| Sep 28, 1994 | K942079 | MANUAL SURGICAL INSTRUMENTS Acufex Microsurgical, Inc. | HRX |
| Sep 28, 1994 | K940290 | ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS Acufex Microsurgical, Inc. | HRX |
| Jul 21, 1994 | K933948 | ACUFEX ENDOBUTTON SYSTEM Acufex Microsurgical, Inc. | MAI |
| Jun 28, 1994 | K932090 | ACUFEX DISPOSABLE MENISCAL CANNULA Acufex Microsurgical, Inc. | HRX |
| Jun 28, 1994 | K931836 | ACUFEX SMOOTH AND THREADED PINS Acufex Microsurgical, Inc. | HTY |
| Jun 16, 1994 | K931519 | ACUFEX SURETAC Acufex Microsurgical, Inc. | JDR |
| May 16, 1994 | K941364 | ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS Acufex Microsurgical, Inc. | HRX |
| May 16, 1994 | K940985 | ACUFEX(R) ARTHROPLASTY INSTRUMENTS Acufex Microsurgical, Inc. | HRX |
| May 16, 1994 | K940981 | ACUFEX LINEAR/ROTARY INSTRUMENTS Acufex Microsurgical, Inc. | HRX |
| May 6, 1994 | K940481 | ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM Acufex Microsurgical, Inc. | HRX |
| Apr 26, 1994 | K940623 | ACUFEX SURETAC IXC SYSTEMS Acufex Microsurgical, Inc. | HRX |
| Apr 26, 1994 | K940506 | ACUFEX ARTHROSCOPIC SUTURE CUTTER Acufex Microsurgical, Inc. | HRX |
| Apr 12, 1994 | K940241 | ACUFEX VIDEO SYSTEM Acufex Microsurgical, Inc. | GCJ |
| Mar 23, 1994 | K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE Acufex Microsurgical, Inc. | HTJ |
| Mar 23, 1994 | K934181 | ACUFEX ADJUSTABLE-LENGTH CANNULA Acufex Microsurgical, Inc. | HRX |
| Mar 22, 1994 | K932460 | ACUFEX MENISCAL RASPS Acufex Microsurgical, Inc. | HRX |
| Mar 21, 1994 | K932718 | ACUFEX METAL ACL CANNULA Acufex Microsurgical, Inc. | HRX |
| Feb 14, 1994 | K934270 | ACUFEX ARTHROSCOPE Acufex Microsurgical, Inc. | HRX |
| Jan 26, 1994 | K933921 | ACUFLEX DISPOSABLE KNIVES Acufex Microsurgical, Inc. | HTS |
| Jan 21, 1994 | K931621 | ACUFEX PRO-PAC AND ISO-PAC Acufex Microsurgical, Inc. | HRX |
| Jan 7, 1994 | K931837 | ACUFEX STERILE DRILLS Acufex Microsurgical, Inc. | HWE |
| Sep 13, 1993 | K930538 | ACUFEX SURETAC(R) PAC Acufex Microsurgical, Inc. | JDR |
| Aug 24, 1993 | K921481 | INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR Acufex Microsurgical, Inc. | HWC |
| Jul 21, 1993 | K911293 | ACUFEX(R) TAG(TM) Acufex Microsurgical, Inc. | JDR |
| Jul 9, 1993 | K922766 | ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION Acufex Microsurgical, Inc. | HTY |
| Jun 22, 1993 | K920620 | FLUORO-SHIELD RADIATION REDUCTION GLOVES Acufex Microsurgical, Inc. | LZC |
| May 5, 1993 | K926036 | ACUFEX SUTURE RETRIEVER Acufex Microsurgical, Inc. | GAE |
| May 5, 1993 | K925573 | ACUFEX T-BAR Acufex Microsurgical, Inc. | HRX |
| May 5, 1993 | K923381 | SOFT TISSUE EXPANDER Acufex Microsurgical, Inc. | HWQ |
| May 5, 1993 | K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE Acufex Microsurgical, Inc. | HWQ |
| Dec 29, 1992 | K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE Acufex Microsurgical, Inc. | HTJ |
| Dec 24, 1992 | K922559 | ACUFEX ENDOFIX BUTTON Acufex Microsurgical, Inc. | EBG |
| Oct 13, 1992 | K924514 | ACUFEX FIXATION POST Acufex Microsurgical, Inc. | HWC |
Newest 50 of 78.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||