CURITY CURAD BANDAGES— 510(k) K810126
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K810126 for CURITY CURAD BANDAGES, Substantially Equivalent on 1981-02-06. Applicant: The Kendal Co.. Device class: 1.
Clearance details
- Applicant
- The Kendal Co.
- Product code
- Code KGX
- Device class
- Class 1
- Regulation
- 21 CFR 880.5240
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KGX
view allMore clearances from The Kendal Co.
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
- K991758 — MONOJECT INSULIN SYRINGE
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
Adverse events under product code KGX
product code KGX- Injury
- 1,590
- Malfunction
- 1,357
- Other
- 3
- Total
- 2,950
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.