Endoscopic Ultrasound Aspiration Needle— 510(k) K172309
Substantially EquivalentMicro-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K172309 for Endoscopic Ultrasound Aspiration Needle, Substantially Equivalent on 2017-09-29. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Product code
- Code ODG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code ODG
view allMore clearances from Micro-Tech (Nanjing) Co., Ltd.
view allAdverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172309
K-number listed on FDA's recall record- Z-1877-2018 — Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
- Z-1878-2018 — Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172309.
Data sourced from openFDA. This site is unofficial and independent of the FDA.