Influence Clip System
FDA 510(k) K981631 · Influence, Inc.
510(k) numberK981631
Submission
- Device name
- Influence Clip System
- Applicant
- Influence, Inc.
Washington, DC, US - Received
- May 7, 1998
- Decision date
- July 28, 1998
- 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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| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
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| K991122 | Cryo-Mono Cryogrnic SystemGEH · Traditional | 07/01/1999SE |
| K990160 | Microtac-Bone Anchor SystemMBI · Special | 02/16/1999SE |
| K990095 | Straight-In-Orthopedic Bone Screw Fixation SystemMBI · Traditional | 02/01/1999SE |
| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | 11/24/1998SE |
| K982155 | Short Straight-In Bone Screw Fixation SystemMBI · Traditional | 08/31/1998SE |
| K980482 | Triangle SlingOTN · Traditional | 03/27/1998SE |
| K972622 | Straight-In Bone Screw Fixation SystemMBI · Traditional | 10/09/1997SE |
Questions and answers
When was Influence Clip System cleared by the FDA?
Influence Clip System (K981631) received a 510(k) decision of Substantially Equivalent on July 28, 1998, 82 days after the submission was received.
What is the product code of K981631?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.