Grasping Forceps
FDA 510(k) K896058 · Annex Medical, Inc.
510(k) numberK896058
Submission
- Device name
- Grasping Forceps
- Applicant
- Annex Medical, Inc.
Eden Prairie, MN, US - Received
- October 18, 1989
- Decision date
- December 28, 1989
- 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 |
| K891352 | Marlow Anal SpeculumKOA · Traditional | Simpson/Basye, Inc. | 06/23/1989SE |
More from Simpson/Basye, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954377 | Forceps, Grasping, Flexible EndoscopicFFL · Traditional | 10/26/1995SE |
| K952863 | Forceps, Biopsy, Non-ElectricFCL · Traditional | 07/19/1995SE |
| K951532 | Metal Ureteral Basket Stone DislodgerFFL · Traditional | 07/19/1995SE |
| K951761 | Metel Ureteral Basket Stone DislodgerFFL · Traditional | 05/11/1995SE |
| K934636 | Annex Medical Flat Wire Stone ExtractorFFL · Traditional | 02/25/1994SE |
| K934675 | Metal Ureteral Basket Stone DislodgerFFL · Traditional | 01/07/1994SE |
| K934598 | Grasping Forceps or Retrieval ForcepsFGO · Traditional | 01/07/1994SE |
| K925267 | Grasping Forceps or Retrieval ForcepsGCJ · Traditional | 02/10/1993SE |
| K925559 | Biliary Stone DislodgerLQR · Traditional | 12/17/1992SE |
| K921401 | Biopsy ForcepsDWZ · Traditional | 10/21/1992SE |
Questions and answers
When was Grasping Forceps cleared by the FDA?
Grasping Forceps (K896058) received a 510(k) decision of Substantially Equivalent on December 28, 1989, 71 days after the submission was received.
What is the product code of K896058?
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.