Acufex Microsurgical, Inc.: FDA filings under this applicant name
FDA lists 78 510(k) clearances under the applicant name “Acufex Microsurgical, Inc.” (first 1980, latest 1996), across 27 product codes in 7 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Smith+Nephew, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 26 | 26 |
| JDR | Staple, Fixation, Bone | 9 | 9 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| KGS | Retention Device, Suture | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| FZX | Guide, Surgical, Instrument | 2 | 2 |
| GAE | Snare, Surgical | 2 | 2 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 2 | 2 |
| HTJ | Gauge, Depth | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
Plus 17 more product codes.
Review panels
- Orthopedic (57)
- General and Plastic Surgery (14)
- General Hospital (2)
- Anesthesiology (1)
- Dental (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Acufex Microsurgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS | JDR | 1996-07-10 | 79 |
| K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER | HRX | 1996-06-21 | 38 |
| K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW | HWC | 1996-02-15 | 157 |
| K952535 | ACUFEX ENDOBUTTON TAPE | GAT | 1996-02-08 | 252 |
| K953276 | ACUFEX TAG DELIVERY SYSTEM | JDR | 1995-10-05 | 83 |
| K953459 | ACUFEX TAG ANCHOR | MBI | 1995-08-23 | 30 |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | KGS | 1995-06-30 | 449 |
| K944500 | ACUFEX PATELLAR BONE BLOCK SIZER | HRX | 1995-06-12 | 271 |
| K951859 | ACUFEX ENDOBUTTON PACK | HRX | 1995-06-09 | 49 |
| K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS | JDR | 1995-04-26 | 117 |
68 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acufex Microsurgical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Acufex Microsurgical, Inc.?
FDA lists 78 510(k) clearances under the applicant name “Acufex Microsurgical, Inc.” (first 1980, latest 1996), across 27 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acufex Microsurgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acufex Microsurgical, Inc. is 108 days.
Which FDA product codes appear under Acufex Microsurgical, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 26); JDR (Staple, Fixation, Bone, 9); HWC (Screw, Fixation, Bone, 6).
Next steps
- See all 78 Acufex Microsurgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Acufex Microsurgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.