Home › Device types › LKF
Cannula, Manipulator/Injector, Uterine
FDA product code LKF · Class 2 · Obstetrics/Gynecology
423
Registered devices
1,804
Adverse events
13
Recalls
87
510(k) clearances
Devices with this code
MIller Advance Catheter — C R IHSG Catheter — TITUS MEDICAL LLCHS Catheters — MedGyn Products, Inc.Goldstein — COOK INCORPORATEDMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.HSG Catheter — TITUS MEDICAL LLCVCARE — Conmed CorporationNA — PANPAC MEDICAL CORPORATIONHYSTERO CATH — ALLWIN MEDICAL DEVICES, INC.ELMED — ELMED INCORPORATEDVIKY — ENDOCONTROLELMED — ELMED INCORPORATEDLTL Medical — Bioteque Taiwan Ltd.VIKY — ENDOCONTROLClearView Uterine Manipulator — CLINICAL INNOVATIONS, LLCInjector — MedGyn Products, Inc.Bioteque — Bioteque Taiwan Ltd.HNM Women Care — HNM STAINLESS, LLC.Sonocath — TITUS MEDICAL LLCBioteque — Bioteque Taiwan Ltd.NA — C R IUterine ElevatOR Pro with OccludOR Balloon — THE O R COMPANY PTY LTDFemCath — FEMASYS INC.Valtchev Uterine Mobilizer — Conkin Surgical Instruments Ltd
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 |
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