510(k) K181127
- Device
- EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
- Applicant
- Interscope, Inc.
- 510(k) number
- K181127
- Product code
- PTE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-03
- Date received
- 2018-04-30
- Regulation
- 884.1690
- Classification name
- Endoscopic Morcellator Gastroenterology
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jeffery Ryan
- Address
- 100 Main St., Suite 108 Whitinsville MA US 01588 01588
FDA Registration Numbers#
- 3011697028
Source Documents#
Other 510(k) Records For Product Code PTE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170120 | EndoRotor | Interscope, Inc. | 2017-04-18 |
Legacy Summary#
summary
FDA Review#
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