Hemo-O-Lok
FDA 510(k) K941972 · King & Spalding
510(k) numberK941972
Submission
- Device name
- Hemo-O-Lok
- Applicant
- King & Spalding
Washington, DC, US - Received
- April 22, 1994
- Decision date
- June 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K942423 | Nais Wrist Blood Pressure MeterDXN · Traditional | 02/15/1995SE |
| K942422 | Panasonic Wrist Blood Pressure MeterDXN · Traditional | 02/15/1995SE |
| K945998 | Chin Implant Style IFWP · Traditional | 02/07/1995SE |
| K944408 | Implantech Medical Grade Silicone SheetingMIB · Traditional | 11/09/1994SE |
| K942421 | Implantech Lateral Mandibular Bar ImplantLZK · Traditional | 08/08/1994SE |
| K942420 | Implantech Midface-Submalar Le Fort ImplantLZK · Traditional | 08/08/1994SE |
Questions and answers
When was Hemo-O-Lok cleared by the FDA?
Hemo-O-Lok (K941972) received a 510(k) decision of Substantially Equivalent on June 29, 1994, 68 days after the submission was received.
What is the product code of K941972?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.