FiXcision
FDA 510(k) K182664 · Agency For Medical Innovations GmbH
510(k) numberK182664
Submission
- Device name
- FiXcision
- Applicant
- Agency For Medical Innovations GmbH
Feldkirch, AT - Received
- September 25, 2018
- Decision date
- December 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOA – Surgical Instruments, G-U, Manual (And Accessories)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950267 | Urethral Suture GuideKOA · Traditional | Applied Medical Resources | 01/31/1995SE |
| K932465 | Li VasectomyKOA · Traditional | Femcare , Ltd. | 03/02/1994SE |
| K921546 | Vasovasostomy SetKOA · Traditional | Cook Urological, Inc. | 07/02/1993SESK |
| K931181 | Vesitec Suture PasserKOA · Traditional | Vesitec Medical, Inc. | 05/12/1993SE |
| K921304 | DDV LigatorKOA · Traditional | North American Medical, Inc. | 10/05/1992SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | Pilling Co. | 09/23/1992SE |
| K921228 | Benderev Protect-A-Pass NeedleKOA · Traditional | Eimark Labs, Inc. | 09/14/1992SE |
| K922192 | Vas DilatorKOA · Traditional | Cook Urological, Inc. | 08/07/1992SE |
| K896058 | Grasping ForcepsKOA · Traditional | Annex Medical, Inc. | 12/28/1989SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | Simpson/Basye, Inc. | 06/23/1989SE |
More from Simpson/Basye, Inc.
Questions and answers
When was FiXcision cleared by the FDA?
FiXcision (K182664) received a 510(k) decision of Substantially Equivalent on December 7, 2018, 73 days after the submission was received.
What is the product code of K182664?
The FDA product code is KOA – Surgical Instruments, G-U, Manual (And Accessories), a Class I (low risk) device regulated under 21 CFR 876.4730.