510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PTEClass II

Endoscopic Morcellator Gastroenterology

21 CFR 884.1690 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PTE is the FDA product code for Endoscopic Morcellator Gastroenterology, a class II device type, regulated under 21 CFR 884.1690. FDA's definition for this code reads: "For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PTE
Device name
Endoscopic Morcellator Gastroenterology
FDA 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)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PTE

By decision year
2 clearances under product code PTE with a decision year between 2017 and 2019, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PTE by decision year
YearClearances
20171
20191

Applicants with the most clearances

Product code PTE
Applicants holding the most 510(k) clearances under product code PTE
ApplicantClearances
Interscope, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code