Coalescent Surgical Sutured-Clip
FDA 510(k) K994160 · Coalescent Surgical
510(k) numberK994160
Submission
- Device name
- Coalescent Surgical Sutured-Clip
- Applicant
- Coalescent Surgical
Sunnyvale, CA, US - Received
- December 9, 1999
- Decision date
- February 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZP – Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating ClipsFZP · Traditional | Taiwan Surgical Corporation | 07/20/2026SE |
| K253903 | InnoClip Disposable Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| K253781 | InnoClip Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| K250643 | Disposable Polymer Ligation ClipsFZP · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 11/20/2025SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | Teleflex Medical | 07/03/2025SE |
| K242541 | Gem ZipclipFZP · Traditional | Synovis Micro Companies Alliance A Subsidiary of… | 01/15/2025SE |
| K221495 | SOLID CLIP Single Use Clip ApplierFZP · Traditional | Medscope Biotech Co., Ltd. | 07/18/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
| K230966 | angiOCCLUDE Ligating ClipsFZP · Traditional | A2 Medical Systems, LLC | 09/19/2023SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | Ethicon Endo Surgery, LLC | 08/29/2023SE |
More from Ethicon Endo Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K040821 | Coalescent Surgical U-Clip and AccessoriesFZP · Traditional | 04/23/2004SE |
| K031623 | Modification to Coalescent Surgical U-Clip and AccessoriesFZP · Special | 07/03/2003SE |
| K024366 | Coalescent Surgical U-Clip and AccessoriesFZP · Special | 01/17/2003SE |
| K023125 | Coalescent U-Clip- and AccessoriesNJU · Traditional | 12/18/2002SE |
| K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesFZP · Traditional | 07/03/2002SE |
| K013664 | Coalescent Surgical U-ClipNCA · Traditional | 01/24/2002SE |
| K012317 | Coalescent Surgical U-ClipFZP · Traditional | 08/31/2001SE |
| K003958 | Coalescent U-Clip Delivery and Disposal DeviceFZP · Traditional | 02/06/2001SE |
Questions and answers
When was Coalescent Surgical Sutured-Clip cleared by the FDA?
Coalescent Surgical Sutured-Clip (K994160) received a 510(k) decision of Substantially Equivalent on February 4, 2000, 57 days after the submission was received.
What is the product code of K994160?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.