Acessory to Modified Freeding Jejunosto
FDA 510(k) K813504 · Midwest Metabolic Support Group
510(k) numberK813504
Submission
- Device name
- Acessory to Modified Freeding Jejunosto
- Applicant
- Midwest Metabolic Support Group
Mchenry, IL, US - Received
- December 15, 1981
- Decision date
- January 7, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| K182664 | FiXcisionKOA · Traditional | Agency For Medical Innovations GmbH | 12/07/2018SE |
| 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 |
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Questions and answers
When was Acessory to Modified Freeding Jejunosto cleared by the FDA?
Acessory to Modified Freeding Jejunosto (K813504) received a 510(k) decision of Substantially Equivalent on January 7, 1982, 23 days after the submission was received.
What is the product code of K813504?
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.