Hatcher Stone Extractor - Disposable Catheter
FDA 510(k) K862949 · Oscor Medical Corp.
510(k) numberK862949
Submission
- Device name
- Hatcher Stone Extractor - Disposable Catheter
- Applicant
- Oscor Medical Corp.
Palm Harbor, FL, US - Received
- August 5, 1986
- Decision date
- October 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQR – Dislodger, Stone, Biliary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253056 | Disposable Stone Extraction BasketLQR · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 04/03/2026SE |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432PLQR · Traditional | Olympus Medical Systems Corp. | 03/18/2025SE |
| K243471 | Extraction BasketLQR · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/16/2024SE |
| K240192 | Single-use Extraction BasketsLQR · Traditional | Scivita Medical Technology Co., Ltd. | 10/15/2024SE |
| K230598 | Stone Extraction BasketsLQR · Traditional | Jiangsu Vedkang Medical Science and Technology… | 09/12/2023SE |
| K203322 | SpyGlass Discover Retrieval BasketLQR · Traditional | Boston Scientific Corporation | 05/26/2021SE |
| K201509 | Disposable Stone Extraction basketLQR · Traditional | Hangzhou AGS MedTech Co., Ltd. | 12/16/2020SE |
| K191789 | Stonetome Stone Removal DeviceLQR · Special | Boston Scientific Corporation | 07/25/2019SESK |
| K182381 | Wilson-Cook Mini BasketLQR · Traditional | Wilson-Cook Medical, Inc. | 10/30/2018SE |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5…LQR · Traditional | Wilson-Cook Medical, Inc. | 03/28/2018SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964107 | Oscor Permanent Retractable Screw-In Pacing Lead Model PRDTB · Traditional | 04/01/1997PT |
| K925168 | Miscellaneous Pacing LeadDTD · Traditional | 05/03/1994SE |
| K923621 | External Demand PacemakerDTE · Traditional | 05/19/1993SE |
| K912867 | Oscor Medical Corp Permanent Pacing LeadDTB · Traditional | 02/04/1992SE |
| K915008 | Permanent Pacing Pad, ModificationDTB · Traditional | 01/27/1992SE |
| K915007 | Permanent Pacing Leads, ModificationDTB · Traditional | 01/27/1992SE |
| K913393 | Implant Pacing Lead, Retractable, ModificationDTB · Traditional | 09/23/1991SE |
| K913205 | Oscor Medical Fix Screw Pac Lead/Peel Cath, ModifDTB · Traditional | 09/23/1991SE |
| K913204 | Model Ky Pacemaker Lead-Various, ModificationDTB · Traditional | 09/23/1991SE |
| K913203 | Implant Pacing Lead Tined #3390, ModificationDTB · Traditional | 09/23/1991SE |
Questions and answers
When was Hatcher Stone Extractor - Disposable Catheter cleared by the FDA?
Hatcher Stone Extractor - Disposable Catheter (K862949) received a 510(k) decision of Substantially Equivalent on October 31, 1986, 87 days after the submission was received.
What is the product code of K862949?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.