MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE— 510(k) K854547
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K854547 for MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE, Substantially Equivalent on 1986-02-04. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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 K854547
K-number listed on FDA's recall record- Z-0424-2021 — Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248
- Z-2036-2019 — Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
- Z-2037-2019 — Monoject Standard Hypodermic Needle Item code: 8881200029
- Z-2038-2019 — Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
- Z-2039-2019 — Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
- Z-2040-2019 — Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
- Z-2041-2019 — Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
- Z-2042-2019 — Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
- Z-2043-2019 — Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
- Z-2044-2019 — Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
- Z-2045-2019 — Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
- Z-2046-2019 — Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
- Z-2047-2019 — Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
- Z-2048-2019 — Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
- Z-2049-2019 — Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
- Z-2050-2019 — Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
- Z-2051-2019 — Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
- Z-2052-2019 — Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K854547.
Data sourced from openFDA. This site is unofficial and independent of the FDA.