Microsurge Laparoscopic Permaclip Cartridge with Implantable Clip
FDA 510(k) K964109 · Microsurge, Inc.
510(k) numberK964109
Submission
- Device name
- Microsurge Laparoscopic Permaclip Cartridge with Implantable Clip
- Applicant
- Microsurge, Inc.
Needham, MA, US - Received
- October 15, 1996
- Decision date
- November 27, 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 |
More from Ethicon Endo Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K960554 | Detachatip Thoracoscopic ScissorsGEI · Traditional | 03/05/1996SE |
| K955408 | Microsurge Thoracoscopic InstrumentsGCJ · Traditional | 01/31/1996SE |
| K954641 | Endo-LeaderOCW · Traditional | 12/28/1995SE |
| K954072 | Microsurge Puncture Close DeviceGCJ · Traditional | 10/26/1995SE |
| K954520 | Microsurge Veress NeedleHET · Traditional | 10/16/1995SE |
| K953121 | Microsurge Thoracoscopic Access SystemGCJ · Traditional | 09/29/1995SE |
| K951230 | Microsurge Bipolar GraspersGEI · Traditional | 06/14/1995SE |
| K933750 | Microsurge Reusable Front End Grasp Devices, ModifGCJ · Traditional | 06/10/1994SE |
| K930355 | Microsurge Suction/Irrigation System CannulasGEI · Traditional | 06/08/1993SE |
| K925830 | Microsurge Suction/Irrigation SystemGEI · Traditional | 05/17/1993SE |
Questions and answers
When was Microsurge Laparoscopic Permaclip Cartridge with Implantable Clip cleared by the FDA?
Microsurge Laparoscopic Permaclip Cartridge with Implantable Clip (K964109) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 43 days after the submission was received.
What is the product code of K964109?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.