Miltex Ligating Clip
FDA 510(k) K052018 · Miltex, Inc.
510(k) numberK052018
Submission
- Device name
- Miltex Ligating Clip
- Applicant
- Miltex, Inc.
York, PA, US - Received
- July 26, 2005
- Decision date
- November 4, 2005
- 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 |
|---|---|---|
| K101653 | Miltex Thompson Cassettes; Miltex Surgical CassettesKCT · Traditional | 08/02/2010SE |
| K092855 | Miltex Membrane Tack KitDZL · Traditional | 12/29/2009SE |
| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…EJI · Traditional | 03/09/2009SE |
| K072563 | Miltex Rigid Container SystemsKCT · Traditional | 02/12/2008SE |
| K061033 | Miltex Rigid Sterilization Container System, (47 Components)KCT · Traditional | 12/12/2006SE |
| K050570 | Miltex Rigid Sterilization Container SystemKCT · Traditional | 07/25/2005SE |
| K043013 | Miltex Laparoscopic InstrumentsHET · Traditional | 03/04/2005SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | 05/01/2002SE |
| K954185 | Re-Bag Multi-Use Pouch, Large & SmallKCT · Traditional | 12/04/1995SESK |
| K823326 | Dental Instruments - Cutting InstrumentELA · Traditional | 11/24/1982SE |
Questions and answers
When was Miltex Ligating Clip cleared by the FDA?
Miltex Ligating Clip (K052018) received a 510(k) decision of Substantially Equivalent on November 4, 2005, 101 days after the submission was received.
What is the product code of K052018?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.