Encapsulated Guidewire with Flexible Tip
FDA 510(k) K914358 · Hobbs Medical, Inc.
510(k) numberK914358
Submission
- Device name
- Encapsulated Guidewire with Flexible Tip
- Applicant
- Hobbs Medical, Inc.
Stafford Springs, CT, US - Received
- October 1, 1991
- Decision date
- November 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EYB – Catheter, Ureteral, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Encapsulated Guidewire with Flexible Tip cleared by the FDA?
Encapsulated Guidewire with Flexible Tip (K914358) received a 510(k) decision of Substantially Equivalent on November 19, 1991, 49 days after the submission was received.
What is the product code of K914358?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.