Arthrocare Corp.: FDA clearances and approvals
Arthrocare Corp. has 149 FDA 510(k) clearances (first 1995, latest 2026), across 15 product codes in 6 review panels. Median 510(k) review time: 57 days. Since 2017 its median was 101 days, against 100 days for all cleared 510(k)s in the same product codes. openFDA lists 14 product recalls by a recalling firm named Arthrocare Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 126 |
| 2013 | 9 | 102 |
| 2014 | 6 | 62 |
| 2015 | 4 | 27 |
| 2016 | 5 | 59 |
| 2017 | 2 | 44 |
| 2018 | 1 | 29 |
| 2019 | 2 | 98 |
| 2020 | 1 | 150 |
| 2021 | 1 | 133 |
| 2022 | 1 | 185 |
| 2023 | 2 | 110 |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 2 | 112 |
Review time against the same product codes
Since 2017, Arthrocare Corp.'s cleared 510(k)s took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 86 | 86 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 31 | 31 |
| HRX | Arthroscope | 7 | 7 |
| NDN | Cement, Bone, Vertebroplasty | 6 | 6 |
| FAS | Electrode, Electrosurgical, Active, Urological | 5 | 5 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| OCW | Endoscopic Tissue Approximation Device | 2 | 2 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
Plus 5 more product codes.
Review panels
- General and Plastic Surgery (88)
- Orthopedic (49)
- Gastroenterology and Urology (8)
- Ear, Nose and Throat (2)
- Dental (1)
- Neurology (1)
Most recent Arthrocare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254122 | FLOW FLEXTEND Wand (72290039) | GEI | 2026-03-30 | 101 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | GEI | 2026-03-25 | 124 |
| K240964 | FLOW 90? Wand | GEI | 2024-05-08 | 29 |
| K232290 | INTELLIO SHIFT System | GEI | 2023-12-11 | 132 |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | GEI | 2023-06-26 | 87 |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | GEI | 2022-09-01 | 185 |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | GEI | 2021-06-24 | 133 |
| K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | GEI | 2020-12-18 | 150 |
| K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | GEI | 2019-12-20 | 144 |
| K183346 | FLOW 90 Wand | GEI | 2019-01-24 | 52 |
139 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2020-08-17.
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 Arthrocare Corp. have?
Arthrocare Corp. has 149 FDA 510(k) clearances (first 1995, latest 2026), across 15 product codes in 6 review panels.
How long does FDA take to clear Arthrocare Corp.'s 510(k)s?
The median time from FDA receipt to decision across Arthrocare Corp.'s cleared 510(k)s is 57 days. Since 2017: 101 days, versus 100 days for all cleared 510(k)s in the same product codes.
What devices does Arthrocare Corp. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 86); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 31); HRX (Arthroscope, 7).
Has Arthrocare Corp. had device recalls?
openFDA lists 14 product recalls in 13 recall events by a recalling firm whose name matches Arthrocare Corp; the most recent began 2020-08-17. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 149 Arthrocare Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Arthrocare Corp.'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.