# K202478: Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Oct 8, 2020 after 41 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950496 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131700: Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy Snares, Boston Scientific Corp (2013) Summary page 4.

## Recalls of this device
- Jan 19, 2021 · Class II · Z-1168-2021: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

## Indications for use
The Captivator and Captiflex Polypectomy Snares are used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Source page: https://510kreport.com/device/K202478
Methodology: https://510kreport.com/methodology