KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH— 510(k) K881667
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K881667 for KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH, Substantially Equivalent on 1988-08-12. Applicant: The Kendal Co.. Device class: 2.
Clearance details
- Applicant
- The Kendal Co.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
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More clearances from The Kendal Co.
view all- K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
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- 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 GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
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.