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Autotome Rx Model # 4515, 4516

by Boston Scientific

510(k) K013153

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

32 ongoing

This device is named in the recall

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013153 Date19 Oct 2001ClearedStatusActive

Recalls

32 recalls · 32 ongoing · FDA

    • Ongoing Z-2350-2024 FDA Class II initiated 12 Jun 2024

    Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.

  • 31 recalls, same reason

    • Ongoing Z-0772-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0765-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0761-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0753-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0771-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0760-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0755-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0780-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0776-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0778-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0767-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0762-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0756-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0751-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0763-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0752-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0781-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0774-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0758-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0775-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0766-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0769-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0764-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0779-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0773-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0770-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0759-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0757-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0768-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0777-2022 FDA Class II initiated 22 Dec 2021
    • Ongoing Z-0754-2022 FDA Class II initiated 22 Dec 2021

    Sterility of device is compromised due to a sterile barrier breach

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNS
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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