Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240
FDA 510(k) K003337 · Weck Closure Systems
510(k) numberK003337
Submission
- Device name
- Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240
- Applicant
- Weck Closure Systems
Research Triangle Park, NC, US - Received
- October 25, 2000
- Decision date
- December 21, 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 |
|---|---|---|
| K011660 | Weck Cardiac Pacing WiresLDF · Traditional | 08/21/2001SE |
| K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, HEM-0-LOK MLX Polymer Clips, Model 544240FZP · Traditional | 12/17/1999SE |
| K982944 | Hem-O-Lock, Model 523935FZP · Traditional | 11/19/1998SE |
| K982941 | Hem-O-Lok Model Numbers 523900, 523970FZP · Traditional | 11/19/1998SE |
| K982313 | Horizon Titanium Clips, Horizon Tantalum ClipsFZP · Traditional | 08/10/1998SE |
Questions and answers
When was Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240 cleared by the FDA?
Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240 (K003337) received a 510(k) decision of Substantially Equivalent on December 21, 2000, 57 days after the submission was received.
What is the product code of K003337?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.