DRG SoftRelease
by Doctor'S Research Group, Inc. 510(k)
Active
510(k) K041018
Overview
The DRG SoftRelease is a cervical spatula used for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). It is classified as a Class II medical device under regulation number 884.4530 and is substantially equivalent to a predicate device.
The device is supplied non-sterile and is intended for single-use. It is used in obstetrics and gynecology settings for specimen collection and is not intended for use in pregnant women. The device received FDA 510(k) clearance under K041018 on October 18, 2004.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041018 | Date18 Oct 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HHT
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Doctor'S Research Group, Inc.
Questions
What is the DRG SoftRelease used for?
The DRG SoftRelease is a cervical spatula designed for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted diseases (STD). It is used in obstetrics and gynecology settings to obtain specimens for laboratory evaluation, enabling cytological screening and infection detection. It is not intended for use in pregnant women.
Is the DRG SoftRelease sterile or non-sterile, and is it reusable?
The DRG SoftRelease is supplied non-sterile and is intended for single-use only. It should not be cleaned, reprocessed, or reused, as doing so may compromise patient safety and device integrity. Single-use design ensures consistent performance and eliminates cross-contamination risks between patients.
What regulatory pathway was used for the DRG SoftRelease, and when was it cleared?
The DRG SoftRelease received FDA 510(k) clearance under submission number K041018 on October 18, 2004. It was determined to be substantially equivalent to a predicate device and classified as a Class II medical device under regulation 884.4530. This clearance pathway confirms its safety and effectiveness for the intended use in cervical cell collection.