THE Rumi System
COLPO-PNEUMO OCCLUDER- Occluding balloon accessory for THE RUMI System
1manufacturer
1catalogue number
4510(k) clearances naming this product code
4recalls on this code
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 |
| Record published | 2022-11-10 |
| Record revised | 2024-02-28 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPO-6 | 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 |
| Advincula Delineator Uterine Manipulator | 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 |
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
4 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 | |
| 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 |
| 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 |
| 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.