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Bipolar Electrosurgical Intraocular Probe

by New England Surgical Instrument Corp.

510(k) K864402

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 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 · Traditional NumberK864402 Date20 Jan 1987ClearedStatusActive

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0658-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0659-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0654-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0656-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0660-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0655-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0657-2025 FDA Class I initiated 14 Nov 2024

    Potential for the outer stainless-steel tube to break or detach.

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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