Reprocessed Stone Retrieval Baskets
FDA 510(k) K012581 · Sterilmed, Inc.
510(k) numberK012581
Submission
- Device name
- Reprocessed Stone Retrieval Baskets
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- August 9, 2001
- Decision date
- February 14, 2002
- 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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|---|---|---|---|
| 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 |
| 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 |
| K955049 | Olympus FG-45/46-1 Grasping ForcepsFFL · Traditional | Olympus America, Inc. | 12/15/1995SE |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | 06/29/2026SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | 10/11/2024SE |
| K190478 | Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | 11/14/2019SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | 04/15/2019SE |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | 06/23/2016SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | 03/23/2016SE |
| K152134 | Reprocessed Vessel SealerNUJ · Traditional | 01/15/2016SE |
Questions and answers
When was Reprocessed Stone Retrieval Baskets cleared by the FDA?
Reprocessed Stone Retrieval Baskets (K012581) received a 510(k) decision of Substantially Equivalent on February 14, 2002, 189 days after the submission was received.
What is the product code of K012581?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.