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VersaOne RC8STS

by Covidien LP

Ref RC8STS

VersaOne RC8STS is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 0763000B00026748P), cleared under FDA 510(k) K201805 on 26 Aug 2020 and listed in FDA GUDID since 22 Jul 2021 (UDI-DI 10884521784024), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201805

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00026748P Basic UDI-DI 10884521784024UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521784024 UDI-DI Date22 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201805 Date26 Aug 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00026748P registered 21 Aug 2026 Active
  • FDA 510(k) K201805 decided 26 Aug 2020 Active
  • FDA GUDID UDI-DI 10884521784024 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

6 dated events

  1. Cleared FDA 510(k) K201805
  2. Listed FDA GUDID 10884521784024
  3. Recall initiated FDA recalls Z-1464-2023
  4. Recall initiated FDA recalls Z-1465-2023
  5. Recall initiated FDA recalls Z-1463-2023
  6. Registered EUDAMED 0763000B00026748P

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VersaOne™ EUDAMED
VersaOne GUDID
Generic name
Laparoscopic multi-instrument access port, single-use
Device name
VersaOne Bladeless Positioning System (S
Model / reference
RC8STS
Primary DI / UDI-DI
10884521784024
Basic UDI-DI
0763000B00026748P
Direct marketing DI
10884521784024
510(k) Number
FDA product code
GCJ
EMDN code
L030199 General surgery surgical cannulas and handpieces, reusable - other
GMDN term
Laparoscopic multi-instrument access port, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER.

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

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)