BML Series
FDA 510(k) K903529 · Olympus Corp.
510(k) numberK903529
Submission
- Device name
- BML Series
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- August 6, 1990
- Decision date
- January 23, 1991
- 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 |
| K902170 | Soehendra Lithotripsy SetLQC · Traditional | Wilson-Cook Medical, Inc. | 07/25/1990SE |
| K860863 | Endo-Tripton, Mechanical Gallstone CrusherLQC · Traditional | George Percy Mcgown | 05/15/1986SE |
More from George Percy Mcgown
| 510(k) | Device | Decision |
|---|---|---|
| K072643 | Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/USKZN · Traditional | 11/16/2007SE |
| K043128 | Olympus EndoarmGWG · Traditional | 12/21/2004SE |
| K042140 | Olympus BF Type UC160-OL8ODG · Traditional | 08/18/2004SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | 07/01/2004SE |
| K040940 | Bronchovideoscope Olympus XBF-D160HMEOQ · Traditional | 04/19/2004SE |
| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
| K933200 | Olympus PBD StentsFGE · Traditional | 04/05/1995SE |
| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
Questions and answers
When was BML Series cleared by the FDA?
BML Series (K903529) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 170 days after the submission was received.
What is the product code of K903529?
The FDA product code is LQC – Lithotriptor, Biliary Mechanical, a Class II (moderate risk) device regulated under 21 CFR 876.4500.