Aesculap
CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (260 mm), diam. 10 mm, consisting of PL520R, PL538R, reusable, reposable, to be used with: PL575SU, PL579T
4manufacturers in China registered for this device type
19catalogue numbers in this listing
4510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 50 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PL575SU | 3 | In distribution | |
| PL475SU | Material : titanium | 12 | In distribution |
| PL468SU | Material : titanium | 12 | In distribution |
| PL608R | Working length (mm) : 260.000 MM | In distribution | |
| PL574T | Material : titanium | 12 | In distribution |
| PL579T | Material : titanium | 12 | In distribution |
| PL603R | Working length (mm) : 205.000 MM | In distribution | |
| PL471SU | Material : titanium | 12 | In distribution |
| PL462SU | Material : titanium | 15 | In distribution |
| PL452SU | Material : titanium | 6 | In distribution |
| PL465SU | Material : titanium | 15 | In distribution |
| PL459SU | Material : titanium | 15 | In distribution |
| PL569T | Material : titanium | 12 | In distribution |
| PL453SU | Material : titanium | 15 | In distribution |
| PL606R | Working length (mm) : 370.000 MM | In distribution | |
| PL506R | Diameter (mm) : 10.000 MM | In distribution | |
| PL450SU | Material : titanium | 15 | In distribution |
| PL572T | Material : titanium | 12 | In distribution |
| PL520R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 321 |
| Teleflex | Teleflex Medical LLC | 57 |
| AtriClip™ LAA Exclusion System | Atricure, Inc. | 40 |
| Medline | Medline Industries, Inc. | 15 |
| AtriClip Flex•v | Atricure, Inc. | 12 |
| E-Pack | Ethicon, Inc. | 12 |
| AtriClip® Pro•v™ LAA Exclusion System | Atricure, Inc. | 12 |
| Titanium Ligation Clip | Vesocclude Medical, LLC | 11 |
| SLS-Clip | Vitalitec Surgical | 10 |
| SLS-Clip Vitalitec | Peters Surgical | 10 |
| MirusTM Ligating Clip | Meril Endo Surgery PVT. Ltd. | 10 |
| Clip 9 Vitalitec | Peters Surgical | 10 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202124 | 2020-09-02 |
| K102081 | 2010-08-06 |
| K081031 | 2008-05-05 |
| K080753 | 2008-04-02 |
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 |
|---|---|---|---|---|---|
| 2021-04-16 | Class II | Under Investigation by firm | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery | 350 units | 2023-01-18 |
| 2021-04-16 | Class II | Under Investigation by firm | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery | 80 units | 2023-01-18 |
| 2018-01-22 | Class II | Labeling design | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information f | 9621 | 2019-09-24 |
| 2018-01-22 | Class II | Labeling design | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions. | 270 | 2019-09-24 |
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.