510(k) DEN200016
- Device
- EndoRotor Device
- Applicant
- Interscope, Inc.
- 510(k) number
- DEN200016
- Product code
- QNE
- Decision
- Unknown (DENG)
- Decision date
- 2020-12-23
- Date received
- 2020-03-16
- Regulation
- 876.4330
- Classification name
- Endoscopic Pancreatic Debridement Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeffery Ryan
- Address
- 100 Main St., Suite 108 Whitinsville MA US 01588 01588
FDA Registration Numbers#
- 3011697028
Source Documents#
510(k) summary PDF not indicated by FDA