DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
FDA 510(k) K200053 · Dannik
510(k) numberK200053
Submission
- Device name
- DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
- Applicant
- Dannik
Winter Park, FL, US - Received
- January 10, 2020
- Decision date
- April 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemGCJ · Traditional | 03/12/2025SE |
| K211019 | Disposable Monopolar Laparoscopic Tips and Reusable HandlesGEI · Traditional | 10/28/2021SE |
| K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable HandlesGEI · Traditional | 08/16/2021SE |
| K201063 | DANNIK Disposable Monopolar Laparoscopic InstrumentGEI · Special | 06/09/2020SE |
| K193019 | DANNIK Disposable Monopolar Laparoscopic InstrumentGEI · Traditional | 03/04/2020SE |
| K192711 | Dannik Titanium Ligation ClipFZP · Traditional | 12/20/2019SE |
| K192643 | Dannik Laparoscopic Suction Irrigation SystemGCJ · Traditional | 11/19/2019SE |
Questions and answers
When was DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) cleared by the FDA?
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) (K200053) received a 510(k) decision of Substantially Equivalent on April 21, 2020, 102 days after the submission was received.
What is the product code of K200053?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.