Ezee Retrieval
FDA 510(k) K180579 · Genicon, Inc.
510(k) numberK180579
Submission
- Device name
- Ezee Retrieval
- Applicant
- Genicon, Inc.
Winter Park, FL, US - Received
- March 5, 2018
- Decision date
- March 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K171752 | X-SurgeGEI · Special | 10/17/2017SE |
| K162059 | Ezee RetrievalGCJ · Special | 09/29/2016SE |
| K132375 | Genistrong Single-Use Specimen Retrieval BagGCJ · Traditional | 06/12/2014SE |
| K100090 | Implantable ClipFZP · Special | 02/02/2010SE |
| K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910GEI · Traditional | 10/10/2006SE |
| K041967 | Genicon Suction Irrigation SystemGCJ · Abbreviated | 11/12/2004SE |
| K041968 | Genicon Bipolar Forceps Model # 600-005-005GEI · Abbreviated | 11/03/2004SE |
Questions and answers
When was Ezee Retrieval cleared by the FDA?
Ezee Retrieval (K180579) received a 510(k) decision of Substantially Equivalent on March 19, 2018, 14 days after the submission was received.
What is the product code of K180579?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.