MONOJECT INSULIN SYRINGE— 510(k) K991758
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K991758 for MONOJECT INSULIN SYRINGE, Substantially Equivalent on 1999-06-14. Applicant: The Kendal Co.. Device class: 2.
Clearance details
- Applicant
- The Kendal Co.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mansfield, MA, US
Recent devices under product code FMF
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view all- K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
- K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
- K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.