Advincula Delineator Uterine Manipulator
The Advincula Delineator is a uterine manipulator used during laparoscopic hysterectomy. Its handle and arched shaft position the uterus, while a sliding Koh-Cup outlines the vaginal…
The Advincula Delineator is a uterine manipulator used during laparoscopic hysterectomy. Its handle and arched shaft position the uterus, while a sliding Koh-Cup outlines the vaginal fornices to provide a landmark for resection.
A distal balloon is built into the shaft, and the cup locks at the selected position. A separate occluder balloon helps maintain pneumoperitoneum during the procedure.
Listed Item
Advincula Delineator Uterine Manipulator with 3.0cm Soft Koh-Efficient
Cup Selection
The soft cup variants have diameters from 2.5 to 4.0 cm and are intended for electrocautery procedures. The device is supplied sterile for single use and supports total laparoscopic, laparoscopic-assisted vaginal and laparoscopic supracervical hysterectomy.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HEW |
| Device type | Culdoscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1640 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K180429 |
| Record published | 2018-08-13 |
| Record revised | 2024-02-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 3 |
| Sizes | Outer diameter 2.5 to 4 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AD750SC-KE30 | Outer Diameter 3.0 cm | In distribution |
| AD750SC-KE25 | Outer Diameter 2.5 cm | In distribution |
| AD750SC-KE40 | Outer Diameter 4.0 cm | In distribution |
| AD750SC-KE35 | Outer Diameter 3.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GelPOINT V-Path | Applied Medical Resources Corp. | 8 |
| Rumi II Koh-Efficient | Coopersurgical, Inc. | 8 |
| Arch Koh-Efficient | Coopersurgical, Inc. | 8 |
| Culdoscope (And Accessories) | Richard Wolf Gmbh | 5 |
| ColpotomizOR Tube | THE O R Company PTY Ltd | 4 |
| ColpotomizOR Tube System | THE O R Company PTY Ltd | 4 |
| Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 4 |
| Koh Cup | Coopersurgical, Inc. | 3 |
| Ultem Koh Cup | Coopersurgical, Inc. | 3 |
| LiNA McCartney Tube | THE O R Company PTY Ltd | 2 |
| ColpotomizOR Tube | Surgi Supplies International PTY. Ltd. | 2 |
| Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 2 |
Showing 12 of 24. All products under Culdoscope (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201086 | 2020-05-21 |
| K180429 | 2018-03-14 |
| K143650 | 2015-07-21 |
| K954311 | 1996-11-19 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2019-06-14 | Class II | Under Investigation by firm | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations. | 213 units in total | 2020-05-19 |
| Coopersurgical, Inc. | 510(k) number | 2019-06-14 | Class II | Under Investigation by firm | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations. | 213 units in total | 2020-05-19 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-23 | Class II | Labeling design | 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. | 6 boxes or 12 units | |
| 2018-09-04 | Class II | Other | The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. | 32538 | 2020-05-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.