# K131700: Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy Snares

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 4, 2013 after 146 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950496 (1995). 4 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941750: Proposed Trademan Microvasive Polypectomy Snares, Boston Scientific Corp (1994) Summary page 1.
- K992477: Rotosnare, Inscope, LLC (1999) Summary page 2.
- K955650: Olympus SD Series Snares, Olympus America, Inc. (1996) Summary page 2.

## Most influential descendants
- K133987: Captivator II,Single-Use Polypectomy Snares (2014), 10 descendants of its own
- K172729: Polypectomy Snare (2018), 5 descendants of its own
- K160637: Rotatable Snares (2016), 4 descendants of its own
- K172758: Rotatable Snares, Non-Rotatable Snares (2018), 3 descendants of its own
- K172734: Single Use Electrosurgical Snare SD-400 (2017), 3 descendants of its own

## Recalls of this device
- Jan 19, 2021 · Class II · Z-1170-2021: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
- Jul 6, 2020 · Class II · Z-2764-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti
- Jul 6, 2020 · Class II · Z-2761-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti
- Jul 6, 2020 · Class II · Z-2763-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti
- Jul 6, 2020 · Class II · Z-2759-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti
- Jul 6, 2020 · Class II · Z-2760-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti
- Jul 6, 2020 · Class II · Z-2765-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti
- Jul 6, 2020 · Class II · Z-2762-2020: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, ti

## Indications for use
The Polypectomy Snares and Rotatable 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/K131700
Methodology: https://510kreport.com/methodology