STD IRRIGATION PUMP— 510(k) K930427
Substantially EquivalentStd Mfg., Inc.
FDA 510(k) clearance K930427 for STD IRRIGATION PUMP, Substantially Equivalent on 1993-06-01. Applicant: Std Mfg., Inc.. Device class: 2.
Clearance details
- Applicant
- Std Mfg., Inc.
- 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
- Stoughton, MA, US
Recent devices under product code GCJ
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- K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
- K012362 — MODIFICATION TO VASCULAR CLOSURE DEVICE
- K003169 — VASCULAR CLOSURE DEVICE
- K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.