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Culdoscope (And Accessories)
FDA product code HEW · Class 2 · Obstetrics/Gynecology
77
Registered devices
258
Adverse events
4
Recalls
18
510(k) clearances
Devices with this code
THE RUMI System — Coopersurgical, Inc.USA Series — Gyrus ACMI, LLCKoh Cup — Coopersurgical, Inc.ColpoWave Colpotomizer — SURGITOOLS PTY. LTD.McCartney Tube — THE O R COMPANY PTY LTDColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD.ColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD.Advincula Delineator™ Uterine Manipulator with 2.5 cm Ultem® Koh-Efficient® — Coopersurgical, Inc.Advincula Delineator Uterine Manipulator — Coopersurgical, Inc.Ultem Koh Cup — Coopersurgical, Inc.GelPOINT V-Path — APPLIED MEDICAL RESOURCES CORPORATIONLiNA McCartney Tube — THE O R COMPANY PTY LTDAdvincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® — Coopersurgical, Inc.RUMI II Koh-Efficient — Coopersurgical, Inc.NA — Richard Wolf GmbHColpotomizOR Tube System — THE O R COMPANY PTY LTDArch Koh-Efficient — Coopersurgical, Inc.RUMI II Koh-Efficient — Coopersurgical, Inc.LiNA McCartney Tube — THE O R COMPANY PTY LTDUltem Koh Cup — Coopersurgical, Inc.Arch Koh-Efficient — Coopersurgical, Inc.NA — Richard Wolf GmbHGelPOINT V-Path — APPLIED MEDICAL RESOURCES CORPORATIONColpotomizOR Tube — THE O R COMPANY PTY LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-23 | CooperSurgical, Inc. | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. |
| 2019-06-14 | CooperSurgical, Inc. | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to |
| 2019-06-14 | CooperSurgical, Inc. | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to |
| 2018-09-04 | CooperSurgical, Inc. | The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. |
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