Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K212852
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle · Micro-Tech (Nanjing) Co., Ltd. · decided 2021-12-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | EUS-19-1-FS2 | Micro-Tech (Nanjing) Co., Ltd. | FCG | 06932503534857 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | EUS-22-0-F | Micro-Tech (Nanjing) Co., Ltd. | FCG ODG | 06932503534642 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | EUS-19-0-FS2 | Micro-Tech (Nanjing) Co., Ltd. | ODG | 06932503534864 |
| Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | EUS-19-1-FS1 | Micro-Tech (Nanjing) Co., Ltd. | FCG | 06932503534697 |
| Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | EUS-22-1-F | Micro-Tech (Nanjing) Co., Ltd. | FCG ODG | 06932503534673 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | EUS-19-0-F | Micro-Tech (Nanjing) Co., Ltd. | FCG ODG | 06932503534635 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | EUS-22-0-FS1 | Micro-Tech (Nanjing) Co., Ltd. | ODG | 06932503534727 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | EUS-19-0-FS1 | Micro-Tech (Nanjing) Co., Ltd. | ODG | 06932503534703 |
| Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | EUS-19-1-F | Micro-Tech (Nanjing) Co., Ltd. | FCG ODG | 06932503534666 |
| Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | EUS-22-1-FS2 | Micro-Tech (Nanjing) Co., Ltd. | FCG | 06932503534871 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | EUS-22-0-FS2 | Micro-Tech (Nanjing) Co., Ltd. | ODG | 06932503534888 |
| Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | EUS-22-1-FS1 | Micro-Tech (Nanjing) Co., Ltd. | FCG | 06932503534710 |