Conmed Trogard Electronic Trocar System
FDA 510(k) K954599 · Conmedcorp
510(k) numberK954599
Submission
- Device name
- Conmed Trogard Electronic Trocar System
- Applicant
- Conmedcorp
Dayton, OH, US - Received
- October 3, 1995
- Decision date
- November 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003965 | MRI Safe InstrumentsGEA · Traditional | Aesculap, Inc. | 03/16/2001SE |
| K982472 | Genicon TrocarGEA · Traditional | Genicon, LC | 02/04/1999SE |
| K922460 | Origin Secondary Cannula and TrocarGEA · Traditional | Origin Medsystems, Inc. | 09/16/1992SE |
| K920110 | Endopath Disposable Thoracic Trocar SleeveGEA · Traditional | ETHICON, Inc. | 04/02/1992SE |
| K911262 | Disposable Specimen Bag W/Cannula and IntroducerGEA · Traditional | ETHICON, Inc. | 06/20/1991SE |
| K904881 | Disposable Yankauer Suction TubeGEA · Traditional | Pilling Medical S.A. | 03/06/1991SE |
| K903416 | Cannula, SurgicalGEA · Traditional | Advantage Diagnostics Corp. | 11/23/1990SE |
| K904218 | Suction SystemGEA · Traditional | Axiom Medical, Inc. | 10/31/1990SE |
| K901718 | Klein Lamprey-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
| K901717 | Klein Micro-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
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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 Electronic Trocar System cleared by the FDA?
Conmed Trogard Electronic Trocar System (K954599) received a 510(k) decision of Substantially Equivalent on November 27, 1995, 55 days after the submission was received.
What is the product code of K954599?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.