Conmed Trogard
FDA 510(k) K934799 · Conmedcorp
510(k) numberK934799
Submission
- Device name
- Conmed Trogard
- Applicant
- Conmedcorp
Utica, NY, US - Received
- October 7, 1993
- Decision date
- December 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
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| K101534 | Conmed Altrus Thermal Tissue Fusion SystemGEI · Traditional | 11/24/2010SE |
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| K050992 | Conmed Irrigation NozzleKPL · Traditional | 07/14/2005SE |
| K050777 | Proforma HF 4.5 Cannula, Model 050906, 050907FGE · Special | 04/22/2005SE |
| K050304 | FX Wire Advanced Measurement GuidewireOCY · Special | 03/08/2005SE |
| K041953 | Versastim, Perfoamax, Surgi-Stim, FaststartGXY · Special | 08/09/2004SE |
| K021079 | Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336XXGEI · Traditional | 07/01/2002SE |
| K021299 | Conmed Heatwave Hand-Controlled EletrodeGEI · Traditional | 06/26/2002SE |
| K020186 | Conmed System 5000 EsuGEI · Traditional | 04/12/2002SE |
| K020135 | Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120GEI · Traditional | 04/12/2002SE |
Questions and answers
When was Conmed Trogard cleared by the FDA?
Conmed Trogard (K934799) received a 510(k) decision of Substantially Equivalent on December 21, 1994, 440 days after the submission was received.
What is the product code of K934799?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.