Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
FDA 510(k) K202478 · Boston Scientific Corporation
510(k) numberK202478
Submission
- Device name
- Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- August 28, 2020
- Decision date
- October 8, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareFDI · Traditional | Intelligent Endoscopy | 11/22/2019SE |
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Questions and answers
When was Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares cleared by the FDA?
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478) received a 510(k) decision of Substantially Equivalent on October 8, 2020, 41 days after the submission was received.
What is the product code of K202478?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.