Pfister-Schwartz Stone Retriever
FDA 510(k) K771302 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK771302
Submission
- Device name
- Pfister-Schwartz Stone Retriever
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Walker, MI, US - Received
- July 15, 1977
- Decision date
- August 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K922542 | Grasping ForcepsFGO · Traditional | Surgitek | 08/19/1992SE |
| K914112 | Metal Ureteral Basket Stone Dislodger, Flat WireFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
More from Annex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K803292 | Field Suction DissectorGDI · Traditional | 01/29/1981SE |
| K792383 | Kelman DipstickHOE · Traditional | 12/11/1979SE |
| K771197 | Norton EndotrachealBTR · Traditional | 08/16/1977SE |
| K770959 | Bougie, Filiform, JacksonKBI · Traditional | 06/14/1977SE |
| K770280 | Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional | 04/15/1977SE |
| K760851 | Converse Altar RetractorKAL · Traditional | 03/10/1977SE |
| K761242 | Teflon Coated Resectoscope SheathFJL · Traditional | 12/16/1976SE |
| K760273 | LithotriteFGK · Traditional | 12/06/1976SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
| K760184 | Element, WorkingFDC · Traditional | 12/02/1976SE |
Questions and answers
When was Pfister-Schwartz Stone Retriever cleared by the FDA?
Pfister-Schwartz Stone Retriever (K771302) received a 510(k) decision of Substantially Equivalent on August 2, 1977, 18 days after the submission was received.
What is the product code of K771302?
The FDA product code is FGO – Dislodger, Stone, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4680.