Genicon Suction Irrigation System
FDA 510(k) K041967 · Genicon
510(k) numberK041967
Submission
- Device name
- Genicon Suction Irrigation System
- Applicant
- Genicon
Maitland, FL, US - Received
- July 21, 2004
- Decision date
- November 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910GEI · Traditional | 10/10/2006SE |
| K041968 | Genicon Bipolar Forceps Model # 600-005-005GEI · Abbreviated | 11/03/2004SE |
Questions and answers
When was Genicon Suction Irrigation System cleared by the FDA?
Genicon Suction Irrigation System (K041967) received a 510(k) decision of Substantially Equivalent on November 12, 2004, 114 days after the submission was received.
What is the product code of K041967?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.