# K181127: EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

- Pathway: 510(k) (Traditional)
- Applicant: Interscope, Inc.
- Decided: Jan 3, 2019 after 248 days
- Product code: PTE (Endoscopic Morcellator Gastroenterology)
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K953695 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170120: EndoRotor, Interscope, Inc. (2017) Summary page 4.

## Indications for use
The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

Source page: https://510kreport.com/device/K181127
Methodology: https://510kreport.com/methodology