STRYKER LAPAROSCOPIC SUCTION IRRIGATOR— 510(k) K934094
Substantially EquivalentStryker Corp.
FDA 510(k) clearance K934094 for STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Substantially Equivalent on 1994-02-18. Applicant: Stryker Corp.. Device class: 2.
Clearance details
- Applicant
- Stryker Corp.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GCJ
view allMore clearances from Stryker Corp.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 K934094
K-number listed on FDA's recall record- Z-2170-2025 — Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Z-1509-2020 — Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip, 0250070452-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, J-TIP, 0250070453-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, L-TIP, 0250070455-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Needle Tip
- Z-0835-2018 — StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934094.
Data sourced from openFDA. This site is unofficial and independent of the FDA.