STRYKER CASSETTE PUMP— 510(k) K042454
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K042454 for STRYKER CASSETTE PUMP, Substantially Equivalent on 2004-12-09. Applicant: Stryker Endoscopy. Device class: 2.
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Code GCX
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GCX
view allMore clearances from Stryker Endoscopy
view all- K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down
- DEN250040 — SportSuite Vision Software
- K253602 — Precision S 4K Sinuscope
- K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Adverse events under product code GCX
product code GCX- Death
- 9
- Malfunction
- 592
- Other
- 2
- Total
- 603
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 K042454
K-number listed on FDA's recall record- Z-2862-2026 — STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
- Z-2863-2026 — STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
- Z-2864-2026 — STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
- Z-0836-2018 — STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042454.
Data sourced from openFDA. This site is unofficial and independent of the FDA.