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Vcare Retractor/Elevator

by Conmed Corporation

510(k) K071907

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K071907↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK071907 Date5 Oct 2007ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

4 recalls · FDA

    • Terminated Z-1520-2011 FDA Unclassified (pre-2012) initiated 2 Feb 2011 on shared 510(k) K071907

    Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all customers who may have unexpired Vcare

  • 3 recalls, same reason

    • Terminated Z-0176-2009 FDA Unclassified (pre-2012) initiated 8 Sep 2008 on shared 510(k) K071907
    • Terminated Z-0177-2009 FDA Unclassified (pre-2012) initiated 8 Sep 2008 on shared 510(k) K071907
    • Terminated Z-0175-2009 FDA Unclassified (pre-2012) initiated 8 Sep 2008 on shared 510(k) K071907

    The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LKF
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vcare Retractor/Elevator is a Uterine Cannula, Manipulator/Injector designed for obstetric and gynecological procedures. It functions as a surgical instrument to retract, elevate, or manipulate tissue during minimally invasive interventions, aiding in visualization and access within the uterine cavity or pelvic region.

Supplied as a single-use device, the Vcare Retractor/Elevator is intended for use in sterile surgical settings, adhering to Class II regulatory standards under the Medical Device Directive (MDD) and FDA 510(k) clearance (K071907). Multiple reference codes (e.g., 1825146, 3030447506) correspond to its regulatory filings, and it is classified under registration number 884.4530 for obstetrics/gynecology applications. Storage and handling follow standard sterile medical device protocols.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures is the VCARE Retractor/Elevator designed to assist with in obstetrics and gynecology?

    The VCARE Retractor/Elevator is specifically designed to retract, elevate, or manipulate tissue during minimally invasive obstetric and gynecological procedures. Its primary use is to improve visualization and access within the uterine cavity or pelvic region, aiding in interventions where precise tissue handling is required.

  • Is the VCARE Retractor/Elevator intended for single-use or repeated use in a clinical setting?

    The VCARE Retractor/Elevator is explicitly supplied as a single-use device. This design ensures patient safety and sterility, as it is intended for use in sterile surgical settings only, adhering to standard medical device protocols.

  • How is the VCARE Retractor/Elevator regulated, and what does that mean for its use in clinical practice?

    The VCARE Retractor/Elevator is classified under the FDA’s 510(k) pathway with clearance number K071907, and it complies with the Medical Device Directive (MDD) under Class II regulatory standards. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness requirements for obstetrics/gynecology applications as defined by registration number 884.4530.

  • What storage and handling precautions should be taken with the VCARE Retractor/Elevator?

    Since the VCARE Retractor/Elevator is a sterile, single-use device, it must be stored and handled according to standard sterile medical device protocols. This includes maintaining the original packaging until immediately before use, protecting it from contamination, and following manufacturer guidelines to preserve sterility and functionality.