FDA product code PTE: Endoscopic Morcellator Gastroenterology
PTE is the FDA product code for endoscopic morcellator gastroenterology. It is a Class II device, regulated under 21 CFR 884.1690 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under PTE. The average 510(k) review took 172 days (median 172).
Definition
For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Morcellator Gastroenterology |
| Device class | Class II |
| Regulation | 21 CFR 884.1690 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PTE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 95 |
| 2019 | 1 | 248 |
Compare with all 510(k) review times · Search every PTE clearance
Top PTE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Interscope, Inc. | 2 | 2019-01-03 |
Most recent PTE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181127 | Interscope, Inc. | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | 2019-01-03 | 248 |
| K170120 | Interscope, Inc. | EndoRotor | 2017-04-18 | 95 |
Recalls for PTE devices
openFDA lists no recalls for product code PTE.
Frequently asked questions
What is FDA product code PTE?
PTE is the FDA product code for endoscopic morcellator gastroenterology. It is a Class II device, regulated under 21 CFR 884.1690 and reviewed by the Gastroenterology and Urology panel.
What device class is PTE?
Class II, regulation 21 CFR 884.1690. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTE?
Across 2 cleared submissions the average was 172 days from receipt to decision (median 172).
Which companies have the most PTE clearances?
Interscope, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PTE
- Run a recall and safety report across every PTE manufacturer
- Watch product code PTE 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times