Grasping Forceps
FDA 510(k) K922542 · Surgitek
510(k) numberK922542
Submission
- Device name
- Grasping Forceps
- Applicant
- Surgitek
Racine, WI, US - Received
- May 29, 1992
- Decision date
- August 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K934598 | Grasping Forceps or Retrieval ForcepsFGO · Traditional | Annex Medical, Inc. | 01/07/1994SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | Critikon Company, LLC | 05/17/1993SE |
| 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 |
|---|---|---|
| K946296 | Quadra-Coil Ureteral StentFAD · Traditional | 03/06/1995SE |
| K944391 | OM-4 (Tenative) Urodynamic Measruement SystemFEN · Traditional | 02/07/1995SE |
| K943491 | Right Angle Urologic Laser FiberGEX · Traditional | 08/05/1994SE |
| K941952 | Surgitek InfuserFAD · Traditional | 05/24/1994SE |
| K933261 | Grasping ForcepsFGO · Traditional | 01/11/1994SE |
| K933260 | Helical Stone/Flatwire Stone BasketsFFL · Traditional | 01/11/1994SE |
| K930733 | Ureteral StentFAD · Traditional | 07/23/1993SE |
| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
| K926344 | Hydrophilic Coated GuidewireKNY · Traditional | 03/05/1993SE |
| K920451 | Endotek Ultra SystemFAP · Traditional | 09/17/1992SE |
Questions and answers
When was Grasping Forceps cleared by the FDA?
Grasping Forceps (K922542) received a 510(k) decision of Substantially Equivalent on August 19, 1992, 82 days after the submission was received.
What is the product code of K922542?
The FDA product code is FGO – Dislodger, Stone, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4680.