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

510(k) K131700

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK131700	Date4 Nov 2013Cleared	StatusActive

8 recalls · 8 ongoing · FDA

- Ongoing Z-1170-2021 FDA Class II initiated 19 Jan 2021
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
7 recalls, same reason
- Ongoing Z-2763-2020 FDA Class II initiated 6 Jul 2020
- Ongoing Z-2761-2020 FDA Class II initiated 6 Jul 2020
- Ongoing Z-2765-2020 FDA Class II initiated 6 Jul 2020
- Ongoing Z-2762-2020 FDA Class II initiated 6 Jul 2020
- Ongoing Z-2759-2020 FDA Class II initiated 6 Jul 2020
- Ongoing Z-2764-2020 FDA Class II initiated 6 Jul 2020
- Ongoing Z-2760-2020 FDA Class II initiated 6 Jul 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, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

1 jurisdiction

United States — FDA 510(k) Active

510(k)