NEPTUNE WASTE MANAGEMENT STSTEM— 510(k) K012991
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K012991 for NEPTUNE WASTE MANAGEMENT STSTEM, Substantially Equivalent on 2001-11-29. Applicant: Stryker Instruments. Device class: 2.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Code FYD
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
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More clearances from Stryker Instruments
view allRecalls naming K012991
K-number listed on FDA's recall record- Z-2061-2012 — Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
- Z-2062-2012 — Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
- Z-2063-2012 — Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
- Z-2064-2012 — Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012991.
Data sourced from openFDA. This site is unofficial and independent of the FDA.