Home › Device types › LKF
Cannula, Manipulator/Injector, Uterine
FDA product code LKF · Class 2 · Obstetrics/Gynecology
417
Registered devices
1,772
Adverse events
13
Recalls
87
510(k) clearances
Devices with this code
Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.HSG Catheter — TITUS MEDICAL LLCELMED — ELMED INCORPORATEDMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.Marina Medical — MARINA MEDICAL INSTRUMENTS, INC.ELMED INCORPORATED — ELMED INCORPORATEDELMED — ELMED INCORPORATEDUterine ElevatOR Pro with OccludOR Balloon — THE O R COMPANY PTY LTDH/S Catheter — TITUS MEDICAL LLCMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.HNM Women Care — HNM STAINLESS, LLC.SALPINX CATH — ALLWIN MEDICAL DEVICES, INC.Uterine ElevatOR PRO with Long Handle™ — THE O R COMPANY PTY LTDNA — C R IColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD.ELMED — ELMED INCORPORATEDH/S Catheter — TITUS MEDICAL LLCVCARE EXTRA LARGE — Conmed CorporationHS Catheters — MEDGYN PRODUCTS, INC.VIKY — ENDOCONTROLVIKY — ENDOCONTROLValtchev Uterine Mobilizer — Conkin Surgical Instruments LtdNA — PANPAC MEDICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage |
| 2019-05-30 | Clinical Innovations, LLC | An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy c |
| 2015-05-18 | CooperSurgical, Inc. | Design of device may expose user to injury to fingers or body parts |
| 2014-07-03 | CooperSurgical, Inc. | Unsealed pouches. |
| 2014-05-13 | CooperSurgical, Inc. | Sterility of the device may be compromised due to unsealed pouch |
| 2012-10-31 | Cooper Surgical, Inc. | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude t |
| 2012-10-31 | Cooper Surgical, Inc. | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude t |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.