BIOPSY NEEDLES & TRAYS— 510(k) K813338
Substantially EquivalentAmerican Pharmaseal Div. Ahsc
FDA 510(k) clearance K813338 for BIOPSY NEEDLES & TRAYS, Substantially Equivalent on 1982-01-28. Applicant: American Pharmaseal Div. Ahsc. Device class: 1.
Clearance details
- Applicant
- American Pharmaseal Div. Ahsc
- Product code
- Code FSH
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FSH
view allMore clearances from American Pharmaseal Div. Ahsc
view allRecalls naming K813338
K-number listed on FDA's recall record- Z-2668-2026 — 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
- Z-1422-2018 — JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K813338.
Data sourced from openFDA. This site is unofficial and independent of the FDA.