Ligamax 5
FDA 510(k) K110699 · Ethicon Endo-Sugery, LLC
510(k) numberK110699
Submission
- Device name
- Ligamax 5
- Applicant
- Ethicon Endo-Sugery, LLC
Cincinnati, OH, US - Received
- March 14, 2011
- Decision date
- March 25, 2011
- 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
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| 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 |
|---|---|---|
| K112033 | Enseal G2 Tissus SealersGEI · Traditional | 11/08/2011SE |
| K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11GEI · Traditional | 06/13/2011SE |
| K091211 | Ees Single Site Laparoscopic Seal Cap Assembly W/Accessories, Model SSL3P, Ees Fixed-…GCJ · Traditional | 09/04/2009SE |
| K082278 | Mammomark, Mammomark MR and Cormark Biopsy Site IdentifiersNEU · Traditional | 12/16/2008SE |
| K080972 | Echelon Zebra Cartridges, Models, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GPGDW · Traditional | 07/03/2008SE |
Questions and answers
When was Ligamax 5 cleared by the FDA?
Ligamax 5 (K110699) received a 510(k) decision of Substantially Equivalent on March 25, 2011, 11 days after the submission was received.
What is the product code of K110699?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.