Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acufex Microsurgical, Inc. — Predicate Candidate Screening
78 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
441 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS | Acufex Microsurgical, Inc. | 1996-07-10 | 79 | 0 |
| K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER | Acufex Microsurgical, Inc. | 1996-06-21 | 38 | 0 |
| K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW | Acufex Microsurgical, Inc. | 1996-02-15 | 157 | 0 |
| K952535 | ACUFEX ENDOBUTTON TAPE | Acufex Microsurgical, Inc. | 1996-02-08 | 252 | 0 |
| K953276 | ACUFEX TAG DELIVERY SYSTEM | Acufex Microsurgical, Inc. | 1995-10-05 | 83 | 0 |
| K953459 | ACUFEX TAG ANCHOR | Acufex Microsurgical, Inc. | 1995-08-23 | 30 | 0 |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | 1995-06-30 | 449 | 0 |
| K944500 | ACUFEX PATELLAR BONE BLOCK SIZER | Acufex Microsurgical, Inc. | 1995-06-12 | 271 | 0 |
| K951859 | ACUFEX ENDOBUTTON PACK | Acufex Microsurgical, Inc. | 1995-06-09 | 49 | 0 |
| K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS | Acufex Microsurgical, Inc. | 1995-04-26 | 117 | 0 |
| K941709 | ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS | Acufex Microsurgical, Inc. | 1995-04-14 | 373 | 0 |
| K943548 | BIOABSORBABLE INTERFERENCE SCREW | Acufex Microsurgical, Inc. | 1995-03-20 | 242 | 0 |
| K934867 | ACUFEX TAG ANCHOR | Acufex Microsurgical, Inc. | 1995-02-09 | 485 | 0 |
| K942442 | ACUFEX T-FIX DELIVERY SYSTEM | Acufex Microsurgical, Inc. | 1994-12-05 | 196 | 0 |
| K942079 | MANUAL SURGICAL INSTRUMENTS | Acufex Microsurgical, Inc. | 1994-09-28 | 152 | 0 |
| K940290 | ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS | Acufex Microsurgical, Inc. | 1994-09-28 | 250 | 0 |
| K942574 | GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER | Acufex Microsurgical, Inc. | 1994-09-28 | 120 | 0 |
| K942846 | ACUFEX(R) ENDO-FEMORAL AIMER | Acufex Microsurgical, Inc. | 1994-09-28 | 104 | 0 |
| K942834 | ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA | Acufex Microsurgical, Inc. | 1994-09-28 | 105 | 0 |
| K933948 | ACUFEX ENDOBUTTON SYSTEM | Acufex Microsurgical, Inc. | 1994-07-21 | 343 | 0 |
| K932090 | ACUFEX DISPOSABLE MENISCAL CANNULA | Acufex Microsurgical, Inc. | 1994-06-28 | 424 | 0 |
| K931836 | ACUFEX SMOOTH AND THREADED PINS | Acufex Microsurgical, Inc. | 1994-06-28 | 441 | 0 |
| K931519 | ACUFEX SURETAC | Acufex Microsurgical, Inc. | 1994-06-16 | 447 | 0 |
| K940981 | ACUFEX LINEAR/ROTARY INSTRUMENTS | Acufex Microsurgical, Inc. | 1994-05-16 | 76 | 0 |
| K940985 | ACUFEX(R) ARTHROPLASTY INSTRUMENTS | Acufex Microsurgical, Inc. | 1994-05-16 | 76 | 0 |
| K941364 | ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS | Acufex Microsurgical, Inc. | 1994-05-16 | 56 | 0 |
| K940481 | ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM | Acufex Microsurgical, Inc. | 1994-05-06 | 93 | 0 |
| K940623 | ACUFEX SURETAC IXC SYSTEMS | Acufex Microsurgical, Inc. | 1994-04-26 | 71 | 0 |
| K940506 | ACUFEX ARTHROSCOPIC SUTURE CUTTER | Acufex Microsurgical, Inc. | 1994-04-26 | 82 | 0 |
| K940241 | ACUFEX VIDEO SYSTEM | Acufex Microsurgical, Inc. | 1994-04-12 | 83 | 0 |
| K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Acufex Microsurgical, Inc. | 1994-03-23 | 49 | 0 |
| K934181 | ACUFEX ADJUSTABLE-LENGTH CANNULA | Acufex Microsurgical, Inc. | 1994-03-23 | 209 | 0 |
| K932460 | ACUFEX MENISCAL RASPS | Acufex Microsurgical, Inc. | 1994-03-22 | 305 | 0 |
| K932718 | ACUFEX METAL ACL CANNULA | Acufex Microsurgical, Inc. | 1994-03-21 | 290 | 0 |
| K934270 | ACUFEX ARTHROSCOPE | Acufex Microsurgical, Inc. | 1994-02-14 | 167 | 0 |
| K933921 | ACUFLEX DISPOSABLE KNIVES | Acufex Microsurgical, Inc. | 1994-01-26 | 169 | 0 |
| K931621 | ACUFEX PRO-PAC AND ISO-PAC | Acufex Microsurgical, Inc. | 1994-01-21 | 294 | 1 |
| K931837 | ACUFEX STERILE DRILLS | Acufex Microsurgical, Inc. | 1994-01-07 | 269 | 0 |
| K930538 | ACUFEX SURETAC(R) PAC | Acufex Microsurgical, Inc. | 1993-09-13 | 223 | 0 |
| K921481 | INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR | Acufex Microsurgical, Inc. | 1993-08-24 | 512 | 0 |
| K911293 | ACUFEX(R) TAG(TM) | Acufex Microsurgical, Inc. | 1993-07-21 | 849 | 0 |
| K922766 | ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION | Acufex Microsurgical, Inc. | 1993-07-09 | 402 | 0 |
| K920620 | FLUORO-SHIELD RADIATION REDUCTION GLOVES | Acufex Microsurgical, Inc. | 1993-06-22 | 497 | 0 |
| K926036 | ACUFEX SUTURE RETRIEVER | Acufex Microsurgical, Inc. | 1993-05-05 | 155 | 0 |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | 1993-05-05 | 300 | 0 |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | 1993-05-05 | 449 | 0 |
| K925573 | ACUFEX T-BAR | Acufex Microsurgical, Inc. | 1993-05-05 | 183 | 1 |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | 1992-12-29 | 68 | 0 |
| K922559 | ACUFEX ENDOFIX BUTTON | Acufex Microsurgical, Inc. | 1992-12-24 | 209 | 0 |
| K924514 | ACUFEX FIXATION POST | Acufex Microsurgical, Inc. | 1992-10-13 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda