Pioneer Pro-Pump
510(k) K914220
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914220 | Date4 Mar 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HHK
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1175
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Pioneer Pro-Pump is a suction curette device classified as a Curette, Suction, Endometrial (And Accessories) under FDA device classification. It is a medical device designed for aspiration procedures, specifically in obstetrics and gynecology settings, as indicated by its advisory committee classification and medical specialty description.
The device is supplied as a reusable or single-use accessory (inferred from device type and clearance context) and operates with adjustable vacuum control down to 500 mmHg. It received FDA 510(k) clearance (K914220) on March 4, 1992, and is manufactured in the USA under regulatory number 884.1175. The device is intended for use in laboratory and clinical environments requiring controlled aspiration, with no claims made about sterility, MRI safety, or storage conditions beyond what is explicitly stated in the data.