Elmed LBC 50-P
FDA 510(k) K926517 · Elmed, Inc.
510(k) numberK926517
Submission
- Device name
- Elmed LBC 50-P
- Applicant
- Elmed, Inc.
Addison, IL, US - Received
- December 30, 1992
- Decision date
- November 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4150
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142525 | PK Lap LoopHIN · Traditional | Olympus Winter & Ibe GmbH | 11/21/2014SE |
| K130305 | Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeHIN · Traditional | Lina Medical Aps | 07/24/2013SE |
| K122983 | Ksea Bipolar ElectrodeHIN · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/26/2013SE |
| K122605 | PKS BillHIN · Special | Gyrus Acmi, Inc. | 12/05/2012SE |
| K113080 | TubalgatorHIN · Traditional | Mectra Labs, Inc. | 06/29/2012SE |
| K111751 | Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop…HIN · Traditional | ETHICON, Inc. | 12/02/2011SE |
| K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)HIN · Traditional | Gyrus Acmi, Inc. | 09/01/2011SE |
| K990147 | Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771HIN · Traditional | Richard Wolf Medical Instruments Corp. | 04/16/1999SE |
| K971565 | Bicoag Coagulating ForcepsHIN · Traditional | Everest Medical Corp. | 03/12/1998SE |
| K943776 | Coagulator Cutter, Endoscopic Bipolar and AccessoriesHIN · Traditional | Richard Wolf Medical Instruments Corp. | 11/03/1994SE |
More from Richard Wolf Medical Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K181173 | ELMED Laparoscopic Instruments and AccessoriesGCJ · Traditional | 03/22/2019SE |
| K010465 | DenstatGEI · Traditional | 05/14/2001SE |
| K974793 | Elmed Esu 120 M/M DigitalGEI · Traditional | 03/19/1998SE |
| K953271 | Elmed Rf-AlertGEI · Traditional | 01/18/1996SE |
| K952110 | Elmed Thermo-FluxGEI · Traditional | 08/14/1995SE |
| K932938 | Elmed Esu 300 M/M and DigitalGEI · Traditional | 05/02/1994SE |
| K921770 | Electrosurgical Units Esu 100L, 100 L M/M & E M/MGEI · Traditional | 05/17/1993SE |
| K915731 | Electrosurgical Units Esu 30, 70, 70 B, 70 DigitalGEI · Traditional | 11/05/1992SE |
| K905417 | Elmed Pneumomat DigitalHIF · Traditional | 01/31/1991SE |
| K881431 | Siemens Stereodynator 828IPF · Traditional | 04/16/1990SE |
Questions and answers
When was Elmed LBC 50-P cleared by the FDA?
Elmed LBC 50-P (K926517) received a 510(k) decision of Substantially Equivalent on November 15, 1994, 685 days after the submission was received.
What is the product code of K926517?
The FDA product code is HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4150.