Forceps, Grasping, Flexible Endoscopic
FDA 510(k) K954377 · Annex Medical, Inc.
510(k) numberK954377
Submission
- Device name
- Forceps, Grasping, Flexible Endoscopic
- Applicant
- Annex Medical, Inc.
Eden Prairie, MN, US - Received
- September 19, 1995
- Decision date
- October 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFL – Dislodger, Stone, Basket, Ureteral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190492 | Peralta Stone Removal CatheterFFL · Traditional | Calcula Technologies, Inc. | 07/18/2019SE |
| K172299 | Accordion Piccolo Stone Management DeviceFFL · Special | Ths International, Inc. D/B/A Accordion Medical | 09/19/2017SE |
| K102887 | Accordion Stone Management Device Model AC281205 and AC3814510FFL · Traditional | Percutaneous Systems, Inc. | 05/16/2011SE |
| K082803 | Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015FFL · Traditional | Percutaneous Systems, Inc. | 11/13/2008SE |
| K052048 | AccordionFFL · Traditional | Percutaneous Systems, Incorporated | 09/13/2005SE |
| K012581 | Reprocessed Stone Retrieval BasketsFFL · Traditional | Sterilmed, Inc. | 02/14/2002SE |
| K972091 | Ams Foreign Body ExtratorFFL · Traditional | American Medical Systems, Inc. | 08/29/1997SE |
| K970489 | Comeg Endoscopy Grasping ForcepsFFL · Traditional | Comeg Endoscopy | 03/19/1997SE |
| K962387 | Olympus FG-45/46-1 Grasping Forceps(Urology)FFL · Traditional | Olympus America, Inc. | 07/31/1996SE |
| K961248 | Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone…FFL · Traditional | C.R. Bard, Inc. | 05/28/1996SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K924027 | Dislodger, Stone, Basket, Ureteral, MetalFFL · Traditional | 10/20/1992SE |
Questions and answers
When was Forceps, Grasping, Flexible Endoscopic cleared by the FDA?
Forceps, Grasping, Flexible Endoscopic (K954377) received a 510(k) decision of Substantially Equivalent on October 26, 1995, 37 days after the submission was received.
What is the product code of K954377?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.