MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES— 510(k) K122653
UnknownKimberly-Clark Corporation
FDA 510(k) clearance K122653 for MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES, Unknown on 2013-06-26. Applicant: Kimberly-Clark Corporation. Device class: 2.
Clearance details
- Applicant
- Kimberly-Clark Corporation
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Roswell, GA, US
Recent devices under product code KNT
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- K231021 — KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K223749 — U by Kotex® Click® Unscented Menstrual Tampons
- K202416 — Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
- K200072 — KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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 K122653
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122653.
Data sourced from openFDA. This site is unofficial and independent of the FDA.