Civ-Flex Holster Cover, Model Sterile, Latex-Free
FDA 510(k) K002546 · CIVCO Medical Instruments Co., Inc.
510(k) numberK002546
Submission
- Device name
- Civ-Flex Holster Cover, Model Sterile, Latex-Free
- Applicant
- CIVCO Medical Instruments Co., Inc.
Kalona, IA, US - Received
- August 17, 2000
- Decision date
- October 31, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Civ-Flex Holster Cover, Model Sterile, Latex-Free cleared by the FDA?
Civ-Flex Holster Cover, Model Sterile, Latex-Free (K002546) received a 510(k) decision of Substantially Equivalent on October 31, 2000, 75 days after the submission was received.
What is the product code of K002546?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.