CURITY 100% SILICONE COUDE' CATHETER— 510(k) K833790
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K833790 for CURITY 100% SILICONE COUDE' CATHETER, Substantially Equivalent on 1983-12-27. Applicant: The Kendal Co.. Device class: 2.
Clearance details
- Applicant
- The Kendal Co.
- Product code
- Code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KOD
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 KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
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 K833790
K-number listed on FDA's recall record- Z-1206-2016 — Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1209-2016 — Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1211-2016 — Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1212-2016 — Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1216-2016 — Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1217-2016 — Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1218-2016 — Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD TRAY COMPONENTS INCLUDING HAND SANITIZER AND SKIN BARR Item Code: P4P18XCSDK¿¿¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1219-2016 — Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1220-2016 — Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1221-2016 — Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1223-2016 — Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1224-2016 — Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1225-2016 — Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1226-2016 — Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1227-2016 — Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1228-2016 — Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1229-2016 — Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K833790.
Data sourced from openFDA. This site is unofficial and independent of the FDA.