PTE · Endoscopic Morcellator Gastroenterology
Obstetrics/Gynecology · 21 CFR 884.1690 · Class 2
Overview
| Product Code | PTE |
|---|---|
| Device Name | Endoscopic Morcellator Gastroenterology |
| Regulation | 21 CFR 884.1690 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Classification Rationale
(1) Class II (performance standards). (2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | Interscope, Inc. | Jan 3, 2019 | SESE |
| K170120 | EndoRotor | Interscope, Inc. | Apr 18, 2017 | SESE |
Top Applicants
- Interscope, Inc. — 2 clearances
