Gem Zipclip
FDA 510(k) K242541 · Synovis Micro Companies Alliance A Subsidiary of Baxter Int
510(k) numberK242541
Submission
- Device name
- Gem Zipclip
- Applicant
- Synovis Micro Companies Alliance A Subsidiary of Baxter Int
Birmingham, AL, US - Received
- August 26, 2024
- Decision date
- January 15, 2025
- 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 |
| 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 |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)FZP · Special | Teleflex Medical | 04/28/2023SE |
Questions and answers
When was Gem Zipclip cleared by the FDA?
Gem Zipclip (K242541) received a 510(k) decision of Substantially Equivalent on January 15, 2025, 142 days after the submission was received.
What is the product code of K242541?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.