Titanium Hemostatic Clip
FDA 510(k) K953258 · Intramed Laboratories, Inc.
510(k) numberK953258
Submission
- Device name
- Titanium Hemostatic Clip
- Applicant
- Intramed Laboratories, Inc.
San Diego, CA, US - Received
- July 12, 1995
- Decision date
- January 5, 1996
- 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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| 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 |
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| K904465 | Flexible ArthroscopeHRX · Traditional | 12/20/1990SE |
| K903528 | LaparoscopeHET · Traditional | 09/04/1990SE |
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Questions and answers
When was Titanium Hemostatic Clip cleared by the FDA?
Titanium Hemostatic Clip (K953258) received a 510(k) decision of Substantially Equivalent on January 5, 1996, 177 days after the submission was received.
What is the product code of K953258?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.