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VersaOne OBTONB11LG

by Covidien LP

VersaOne OBTONB11LG is a Class II device made by Covidien LP, cleared under FDA 510(k) K201805 on 26 Aug 2020 and listed in FDA GUDID since 22 Jul 2021 (UDI-DI 10884521785854), active as of 23 Oct 2026. 3 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

3 ongoing

This device is named in the recall

Documents

510(k) K201805

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521785854 UDI-DI Date22 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201805 Date26 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201805 decided 26 Aug 2020 Active
  • FDA GUDID UDI-DI 10884521785854 listed 22 Jul 2021 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1464-2023 FDA Class II initiated 22 Mar 2023
    • Ongoing Z-1465-2023 FDA Class II initiated 22 Mar 2023
    • Ongoing Z-1463-2023 FDA Class II initiated 22 Mar 2023

    There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

Timeline

5 dated events

  1. Cleared FDA 510(k) K201805
  2. Listed FDA GUDID 10884521785854
  3. Recall initiated FDA recalls Z-1464-2023
  4. Recall initiated FDA recalls Z-1465-2023
  5. Recall initiated FDA recalls Z-1463-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VersaOne
Generic name
Laparoscopic multi-instrument access port, single-use
Model / reference
OBTONB11LG
Primary DI / UDI-DI
10884521785854
510(k) Number
FDA product code
GCJ
GMDN term
Laparoscopic multi-instrument access port, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 11 Millimeter

Related devices

Category: Laparoscopic multi-instrument access port, single-use

Cleared under the same submission (K201805)

and 8 more cleared under K201805

Similar devices in this category

Other devices filed under Laparoscopic multi-instrument access port, single-use.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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