FDA product code PTS: Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
PTS is the FDA product code for endoscopic grasping/cutting instrument, non-powered, exempt. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under PTS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PTS devices
openFDA lists no recalls for product code PTS.
Frequently asked questions
What is FDA product code PTS?
PTS is the FDA product code for endoscopic grasping/cutting instrument, non-powered, exempt. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is PTS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PTS
- Run a recall and safety report across every PTS manufacturer
- Watch product code PTS 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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