Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)
FDA 510(k) K111059 · Gyrus Acmi, Inc.
510(k) numberK111059
Submission
- Device name
- Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)
- Applicant
- Gyrus Acmi, Inc.
Southborough, MA, US - Received
- April 18, 2011
- Decision date
- September 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
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| K111751 | Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop…HIN · Traditional | ETHICON, Inc. | 12/02/2011SE |
| 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 |
| K926517 | Elmed LBC 50-PHIN · Traditional | Elmed, Inc. | 11/15/1994SE |
| K943776 | Coagulator Cutter, Endoscopic Bipolar and AccessoriesHIN · Traditional | Richard Wolf Medical Instruments Corp. | 11/03/1994SE |
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Questions and answers
When was Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) cleared by the FDA?
Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (K111059) received a 510(k) decision of Substantially Equivalent on September 1, 2011, 136 days after the submission was received.
What is the product code of K111059?
The FDA product code is HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4150.