Turkel Abdominal Paracentesis System
FDA 510(k) K924702 · Symbiosis Corp.
510(k) numberK924702
Submission
- Device name
- Turkel Abdominal Paracentesis System
- Applicant
- Symbiosis Corp.
Miami, FL, US - Received
- September 17, 1992
- Decision date
- January 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Decision |
|---|---|---|
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| K953453 | Symbiosis Monopolar Electrosurgical Roller ElectrodesFAS · Traditional | 01/17/1996SE |
| K953242 | Symbiosis Monoplar Electrosurgical ElectrodesKNF · Traditional | 10/06/1995SE |
| K952432 | Symbiosis Bipolar ForcepsGEI · Traditional | 07/05/1995SE |
| K951387 | Symbiosis Bipolar ScissorsGCJ · Traditional | 04/10/1995SE |
| K950286 | Symbiosis Bipolar ScissorsGCJ · Traditional | 02/03/1995SE |
| K946238 | Symbiosis Gastrointestinal Biopsy ForcepsFCL · Traditional | 01/20/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | 07/28/1994SE |
| K941426 | Symbiosis Reusable Monopolar Electrosurgical ProbeGEI · Traditional | 06/22/1994SE |
| K932266 | Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanKGE · Traditional | 03/15/1994SE |
Questions and answers
When was Turkel Abdominal Paracentesis System cleared by the FDA?
Turkel Abdominal Paracentesis System (K924702) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 117 days after the submission was received.
What is the product code of K924702?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.