Company · US
Laborie Medical Technologies, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2024. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
3recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FEN | Device, Cystometric, Hydraulic | 5 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 |
| FFX | System, Gastrointestinal Motility (Electrical) | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 |
| KPN | Alarm, Conditioned Response Enuresis | 2 |
| EXQ | Cystometer, Electrical Recording | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 |
| FHA | Clamp, Penile | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| HIR | Perineometer | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 1 |
| LKY | Device, External Penile Rigidity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2024 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) Laborie Medical Technologies, Corp. | FBK |
| May 6, 2024 | K240007 | Solar Compact (G4-1) Laborie Medical Technologies, Corp. | FFX |
| Apr 23, 2024 | K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) Laborie Medical Technologies, Corp. | KLA |
| Jul 21, 2009 | K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP Laborie Medical Technologies, Ltd. | FBK |
| Mar 6, 2009 | K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE Laborie Medical Technologies, Inc. | GWF |
| Jul 9, 2008 | K081781 | NUWAV Laborie Medical Technologies, Corp. | IYO |
| Mar 5, 2008 | K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY Laborie Medical Technologies, Corp. | FEN |
| May 4, 2007 | K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES Laborie Medical Technologies | KPI |
| May 20, 1997 | K962009 | UROSTYM Laborie Medical Technologies, Ltd. | KPI |
| Feb 16, 1996 | K955856 | TEX-AID BLUE Laborie Medical Technologies, Ltd., CA | LKY |
| Jan 24, 1996 | K955810 | U-TEX Laborie Medical Technologies, Ltd., CA | FHA |
| Jul 6, 1995 | K951805 | PIPER, MODEL NUMBER UDS-PIPERB Laborie Medical Technologies, Ltd., CA | FEN |
| Jun 6, 1995 | K942563 | ELITE BIOFEEDBACK Laborie Medical Technologies, Ltd. | HIR |
| Jul 12, 1994 | K942023 | INFUSION PUMP, MODEL NO. UDP-5 Laborie Medical Technologies, Ltd. | FEN |
| Nov 24, 1993 | K934369 | DRI SLEEPER Laborie Medical Technologies, Ltd., CA | KPN |
| Aug 5, 1993 | K931574 | ADVANCE MODEL UDS-ADV Laborie Medical Technologies, Ltd., CA | EXQ |
| Mar 3, 1993 | K930005 | DRITRAINER Laborie Medical Technologies, Ltd. | KPN |
| Oct 20, 1992 | K924086 | NICKI, MODEL NUMBER USD-NK-UP1 Laborie Medical Technologies, Ltd. | FAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Laborie Medical Technologies Corp Solar GI System (Water Perfusion);
Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley syste Open, Classified |
FFX | K121014 |
| Jul 17, 2019 | LABORIE MEDICAL TECHNOLOGIES, CORP U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions Terminated |
FEN | None listed |
| Dec 1, 2006 | Laborie Medical Technologies Laborie Transducer Cartridge with Luer Lock
Reference: DIS130 Terminated |
FEN | None listed |