FDA product code OEW: Tracking, Soft Tissue, Intraoperative
OEW is the FDA product code for tracking, soft tissue, intraoperative. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under OEW, from 2 different applicants. The average 510(k) review took 197 days (median 200). FDA has posted 1 recall for OEW devices, 1 initiated in the last five years.
Definition
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
Classification
| Field | Value |
|---|---|
| Device name | Tracking, Soft Tissue, Intraoperative |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every OEW clearance
Top OEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pathfinder Therapeutics, Inc. | 3 | 2011-02-09 |
| Cascination AG | 1 | 2015-04-28 |
Most recent OEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143024 | Cascination AG | CAS-One Liver | 2015-04-28 | 189 |
| K101979 | Pathfinder Therapeutics, Inc. | EXPLORER LIVER (PASSIVE TRACKING) | 2011-02-09 | 210 |
| K093494 | Pathfinder Therapeutics, Inc. | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | 2010-03-30 | 140 |
| K071063 | Pathfinder Therapeutics, Inc. | LINASYS | 2007-12-20 | 248 |
Recalls for OEW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code OEW?
OEW is the FDA product code for tracking, soft tissue, intraoperative. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the General and Plastic Surgery panel.
What device class is OEW?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEW?
Across 4 cleared submissions the average was 197 days from receipt to decision (median 200).
Which companies have the most OEW clearances?
Pathfinder Therapeutics, Inc. (3); Cascination AG (1).
Have OEW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OEW
- Run a recall and safety report across every OEW manufacturer
- Watch product code OEW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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