Fast Throw Stainless Steel Surgical Suture
FDA 510(k) K030926 · Advanced Surgical Products, Inc.
510(k) numberK030926
Submission
- Device name
- Fast Throw Stainless Steel Surgical Suture
- Applicant
- Advanced Surgical Products, Inc.
Sunnyvale, CA, US - Received
- March 24, 2003
- Decision date
- July 21, 2003
- 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 |
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| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
| K230966 | angiOCCLUDE Ligating ClipsFZP · Traditional | A2 Medical Systems, LLC | 09/19/2023SE |
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| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
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Questions and answers
When was Fast Throw Stainless Steel Surgical Suture cleared by the FDA?
Fast Throw Stainless Steel Surgical Suture (K030926) received a 510(k) decision of Substantially Equivalent on July 21, 2003, 119 days after the submission was received.
What is the product code of K030926?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.