Endo-Tripton, Mechanical Gallstone Crusher
FDA 510(k) K860863 · George Percy Mcgown
510(k) numberK860863
Submission
- Device name
- Endo-Tripton, Mechanical Gallstone Crusher
- Applicant
- George Percy Mcgown
Pembroke Pines, FL, US - Received
- March 7, 1986
- Decision date
- May 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQC – Lithotriptor, Biliary Mechanical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040447 | Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088LQC · Special | Boston Scientific Corp | 03/12/2004SE |
| K011178 | Wilson-Cook Thru-The-Scope Mechanical LithotriptorLQC · Special | Wilson-Cook Medical, Inc. | 05/04/2001SE |
| K964937 | A Lithotripter-Compatible BasketLQC · Traditional | Boston Scientific Corp | 01/24/1997SE |
| K942544 | Gip/Medi-Globe Mechanical Lithotriptor and BasketsLQC · Traditional | Medi-Globe Corp. | 11/22/1994SE |
| K943191 | Microvasive(R) Monolith(Tm) Mechanical LithotriptorLQC · Traditional | Boston Scientific Corp | 08/29/1994SE |
| K905552 | LaparolithLQC · Traditional | Baxter Healthcare Corp | 12/17/1991SE |
| K911364 | Spoon Forceps, 11MMLQC · Traditional | Northgate Technologies, Inc. | 10/23/1991SE |
| K911477 | Laparoscopic Basket Flexible and RigidLQC · Traditional | United States Endoscopy Group, Inc. | 08/14/1991SE |
| K903529 | BML SeriesLQC · Traditional | Olympus Corp. | 01/23/1991SE |
| K902170 | Soehendra Lithotripsy SetLQC · Traditional | Wilson-Cook Medical, Inc. | 07/25/1990SE |
Questions and answers
When was Endo-Tripton, Mechanical Gallstone Crusher cleared by the FDA?
Endo-Tripton, Mechanical Gallstone Crusher (K860863) received a 510(k) decision of Substantially Equivalent on May 15, 1986, 69 days after the submission was received.
What is the product code of K860863?
The FDA product code is LQC – Lithotriptor, Biliary Mechanical, a Class II (moderate risk) device regulated under 21 CFR 876.4500.