Grasping Forceps or Retrieval Forceps
FDA 510(k) K934598 · Annex Medical, Inc.
510(k) numberK934598
Submission
- Device name
- Grasping Forceps or Retrieval Forceps
- Applicant
- Annex Medical, Inc.
Eden Prairie, MN, US - Received
- September 24, 1993
- Decision date
- January 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGO – Dislodger, Stone, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001563 | Scipro(Tm) Flexible Stone Dislodger and Retrieval SetFGO · Traditional | Scion Cardiovascular, Inc. | 11/22/2000SE |
| K970121 | Stone Dislodger, BasketFGO · Traditional | Boston Scientific Corp | 04/02/1997SE |
| K963750 | Retrieval SnareFGO · Traditional | Boston Scientific Corp | 11/22/1996SE |
| K962676 | Disposable Endoscopic Retrieval DeviceFGO · Traditional | United States Endoscopy Group, Inc. | 10/04/1996SE |
| K951309 | Stone Dislodger, BasketFGO · Traditional | Boston Scientific Corp | 05/17/1995SE |
| K933261 | Grasping ForcepsFGO · Traditional | Surgitek | 01/11/1994SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | Critikon Company, LLC | 05/17/1993SE |
| K922542 | Grasping ForcepsFGO · Traditional | Surgitek | 08/19/1992SE |
| K914112 | Metal Ureteral Basket Stone Dislodger, Flat WireFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
| K914111 | Metal Ureteral Basket Stone Dislodger, HelicalFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
More from Annex Medical, 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 |
| 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 Grasping Forceps or Retrieval Forceps cleared by the FDA?
Grasping Forceps or Retrieval Forceps (K934598) received a 510(k) decision of Substantially Equivalent on January 7, 1994, 105 days after the submission was received.
What is the product code of K934598?
The FDA product code is FGO – Dislodger, Stone, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4680.