URETERAL DOUBLE PIGTAIL STENT— 510(k) K834401
Substantially EquivalentHobbs Medical, Inc.
FDA 510(k) clearance K834401 for URETERAL DOUBLE PIGTAIL STENT, Substantially Equivalent on 1984-03-22. Applicant: Hobbs Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Hobbs Medical, Inc.
- Product code
- Code FAD
- Device class
- Class 2
- Regulation
- 21 CFR 876.4620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FAD
view allMore clearances from Hobbs Medical, Inc.
view allAdverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
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 K834401
K-number listed on FDA's recall record- Z-0037-2023 — Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
- Z-0038-2023 — Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
- Z-0039-2023 — Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
- Z-0040-2023 — Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
- Z-0041-2023 — Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
- Z-0042-2023 — Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
- Z-0043-2023 — Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104
- Z-0044-2023 — Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105
- Z-0045-2023 — Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K834401.
Data sourced from openFDA. This site is unofficial and independent of the FDA.