FDA product code ODY: Tunneled Catheter Remover
ODY is the FDA product code for tunneled catheter remover. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under ODY, from 2 different applicants. The average 510(k) review took 204 days (median 204). FDA has posted 1 recall for ODY devices, 1 initiated in the last five years.
Definition
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.
Classification
| Field | Value |
|---|---|
| Device name | Tunneled Catheter Remover |
| Device class | Class II |
| Regulation | 21 CFR 880.5970 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ODY clearance
Top ODY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Symmetry Medical | 1 | 2012-09-28 |
| Tran Pa-C, Inc. | 1 | 2007-09-14 |
Most recent ODY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122263 | Symmetry Medical | 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE | 2012-09-28 | 63 |
| K063048 | Tran Pa-C, Inc. | TRANS-CATHETER EXTRACTOR | 2007-09-14 | 345 |
Recalls for ODY devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-06-11.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code ODY?
ODY is the FDA product code for tunneled catheter remover. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel.
What device class is ODY?
Class II, regulation 21 CFR 880.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODY?
Across 2 cleared submissions the average was 204 days from receipt to decision (median 204).
Which companies have the most ODY clearances?
Symmetry Medical (1); Tran Pa-C, Inc. (1).
Have ODY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-06-11.
Next steps
- Run an FDA pathway report with predicate devices for product code ODY
- Run a recall and safety report across every ODY manufacturer
- Watch product code ODY 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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