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Culdoscope (And Accessories)
FDA product code HEW · Class 2 · Obstetrics/Gynecology
77
Registered devices
251
Adverse events
4
Recalls
18
510(k) clearances
Devices with this code
GelPOINT V-Path — APPLIED MEDICAL RESOURCES CORPORATIONColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD.ColpoWave Colpotomizer — SURGITOOLS PTY. LTD.RUMI II Koh-Efficient — Coopersurgical, Inc.LiNA McCartney Tube — THE O R COMPANY PTY LTDArch Koh-Efficient — Coopersurgical, Inc.Ultem Koh Cup — Coopersurgical, Inc.FertiloScope — VIO HEALTHTECH LIMITEDAdvincula Delineator Uterine Manipulator — Coopersurgical, Inc.GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device — APPLIED MEDICAL RESOURCES CORPORATIONColpotomizOR Tube System — THE O R COMPANY PTY LTDGelPOINT V-Path — APPLIED MEDICAL RESOURCES CORPORATIONAdvincula Delineator Uterine Manipulator — Coopersurgical, Inc.ColpotomizOR Tube System — THE O R COMPANY PTY LTDUltem Koh Cup — Coopersurgical, Inc.USA Series — Gyrus ACMI, LLCRUMI II Koh-Efficient — Coopersurgical, Inc.GelPOINT V-Path — APPLIED MEDICAL RESOURCES CORPORATIONKoh Cup — Coopersurgical, Inc.NA — Richard Wolf GmbHColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD.Arthrex® — ARTHREX, INC.ColpotomizOR Tube — THE O R COMPANY PTY LTDNA — Richard Wolf GmbH
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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