Tubalgator
FDA 510(k) K113080 · Mectra Labs, Inc.
510(k) numberK113080
Submission
- Device name
- Tubalgator
- Applicant
- Mectra Labs, Inc.
Bloomfield, IN, US - Received
- October 18, 2011
- Decision date
- June 29, 2012
- 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
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| K926517 | Elmed LBC 50-PHIN · Traditional | Elmed, Inc. | 11/15/1994SE |
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More from Richard Wolf Medical Instruments Corp.
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| K993604 | Endoscopic Anti Fog DeviceOCT · Traditional | 03/03/2000SE |
| K955352 | Suction Cautery ProbeGEI · Traditional | 04/05/1996SE |
| K934547 | Mectra TrocarGCJ · Traditional | 02/18/1994SE |
| K935382 | GraspersGCJ · Traditional | 02/15/1994SE |
| K925691 | Insufflation TubingHIF · Traditional | 09/23/1993SE |
| K920959 | Insufflator, LaparoscopicHIF · Traditional | 07/13/1992SE |
Questions and answers
When was Tubalgator cleared by the FDA?
Tubalgator (K113080) received a 510(k) decision of Substantially Equivalent on June 29, 2012, 255 days after the submission was received.
What is the product code of K113080?
The FDA product code is HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4150.