Flexible Cystoscopy Introducing Catheter
FDA 510(k) K921120 · Cook Urological, Inc.
510(k) numberK921120
Submission
- Device name
- Flexible Cystoscopy Introducing Catheter
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- March 9, 1992
- Decision date
- August 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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| K251599 | Single-use Ureteral Access SheathFED · Special | Hunan Vathin Medical Instrument Co., Ltd. | 07/03/2025SE |
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Questions and answers
When was Flexible Cystoscopy Introducing Catheter cleared by the FDA?
Flexible Cystoscopy Introducing Catheter (K921120) received a 510(k) decision of Substantially Equivalent on August 4, 1992, 148 days after the submission was received.
What is the product code of K921120?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.