Mitek Surgical Products, Inc.: FDA clearances and approvals
Mitek Surgical Products, Inc. has 31 FDA 510(k) clearances (first 1989, latest 1996), across 10 product codes in 4 review panels. Median 510(k) review time: 169 days.
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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 16 | 16 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 4 | 4 |
| MNV | Strip, Dialysate Ph Indicator | 3 | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| FLE | Sterilizer, Steam | 1 | 1 |
| GFG | Bit, Surgical | 1 | 1 |
| HTW | Bit, Drill | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| HXY | Brace, Drill | 1 | 1 |
| KGS | Retention Device, Suture | 1 | 1 |
Review panels
Most recent Mitek Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953560 | MITEK THREADED ANCHOR (FASTIN) | MBI | 1996-01-31 | 195 |
| K953877 | MITEK GII ANCHOR | MBI | 1995-12-29 | 165 |
| K936311 | MITEK MINI ANCHOR | MNV | 1995-10-31 | 559 |
| K941599 | MITEK ABSORBABLE ANCHOR | MNV | 1995-10-24 | 571 |
| K944051 | ABSORBALBE ANCHOR | MNV | 1995-08-02 | 348 |
| K950070 | MITEK TOGGLE ANCHOR(TM) | JDR | 1995-05-22 | 133 |
| K944936 | MITEK G III ANCHOR, MITEK LS ANCHOR | JDR | 1995-03-24 | 169 |
| K945203 | MITEK THRADED ANCHOR (MTA) | JDR | 1995-03-06 | 132 |
| K934366 | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER | HWC | 1994-10-07 | 395 |
| K931782 | MITEK GIII ANCHOR | JDR | 1994-07-22 | 469 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mitek Surgical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Mitek Surgical Products, Inc. have?
Mitek Surgical Products, Inc. has 31 FDA 510(k) clearances (first 1989, latest 1996), across 10 product codes in 4 review panels.
How long does FDA take to clear Mitek Surgical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mitek Surgical Products, Inc.'s cleared 510(k)s is 169 days.
What devices does Mitek Surgical Products, Inc. make?
Its most frequent FDA product codes are JDR (Staple, Fixation, Bone, 16); GAS (Suture, Nonabsorbable, Synthetic, Polyester, 4); MNV (Strip, Dialysate Ph Indicator, 3).
Has Mitek Surgical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mitek Surgical Products, Inc. Related entities may recall under other names.
Next steps
- See all 31 Mitek Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDR, Mitek Surgical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.