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AngiOptic 10605106

by Angiodynamics, Inc.

AngiOptic 10605106 is a Class II device made by Angiodynamics, Inc., cleared under FDA 510(k) K161596 on 28 Apr 2017 (1 earlier submission) and listed in FDA GUDID since 13 Sep 2016 (UDI-DI H787106051060), active as of 23 Oct 2026. 21 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

20 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161596 Date28 Apr 2017DecidedStatusActive
United StatesGUDID listing NumberH787106051060 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161596 decided 28 Apr 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI H787106051060 listed 13 Sep 2016 Listed

Recalls

21 recalls · 20 ongoing · FDA

  • 20 recalls, same reason

    • Ongoing Z-1862-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1873-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1863-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1866-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1872-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1859-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1871-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1858-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1860-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1864-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1875-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1870-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1856-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1869-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1867-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1865-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1874-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1861-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1857-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1868-2026 FDA Class II initiated 3 Mar 2026

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

    • Terminated Z-0742-2018 FDA Class II initiated 22 Sep 2017

    Product was placed into distribution prior to completion of all required post sterilization release activities.

Timeline

24 dated events

  1. Recall initiated FDA recalls Z-1875-2026
  2. Recall initiated FDA recalls Z-1870-2026
  3. Recall initiated FDA recalls Z-1856-2026
  4. Recall initiated FDA recalls Z-1869-2026
  5. Recall initiated FDA recalls Z-1867-2026
  6. Recall initiated FDA recalls Z-1865-2026
  7. Recall initiated FDA recalls Z-1874-2026
  8. Recall initiated FDA recalls Z-1861-2026
  9. Recall initiated FDA recalls Z-1857-2026
  10. Recall initiated FDA recalls Z-1868-2026

14 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AngiOptic
Generic name
Angiographic catheter, single-use
Model / reference
10605106
Primary DI / UDI-DI
H787106051060
510(k) Number
FDA product code
DQO
GMDN term
Angiographic catheter, single-use
Device class
Class II
Regulation number
870.1200
GUDID distribution status
In Commercial Distribution
Size
Length — 80 Centimeter
Catheter Gauge — 3 French

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K112452)

and 8 more cleared under K112452

Cleared under the same submission (K161596)

and 8 more cleared under K161596

Similar devices in this category

Other devices filed under Angiographic catheter, single-use.

Other devices from Angiodynamics, Inc.

See all devices from Angiodynamics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)