Cytology Brush
510(k) K971849
Cytology Brush is a medical device (FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by Team Technologies, Inc., cleared under FDA 510(k) K971849 on 24 Jul 1997, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971849 | Date24 Jul 1997 | StatusActive |
Official records
- FDA 510(k) database K971849
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Similar devices
Other devices filed under FDA product code HHT (Spatula, Cervical, Cytological).
- Kolplast Cervical Sample Collection Kit by Kolplast CI SA
- HISTOBRUSH by PURITAN MEDICAL PRODUCTS COMPANY LLC
- SPATULA FOR PAP SMEAR COLLECTION by Medical Device Inspection Co., Inc.
- CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 by Canadian Medical Brush, Inc.
- CHLAMYDIA KIT, STD KIT by Intl. Cytobrush, Inc.
- PC-BEADS POSTCOITAL TEST by Microscopy Research Innovations
- CYTOBRUSH by Laboratoire Ccd C/O Washington Regulatory Services
- MICRO-PAP(TM) KIT by Micro-Pap Corp.
- CERVICAL-VAGINAL SPATULA by Law Offices of Natter & Natter
- SAFETEX CERVICAL SCRAPER (PLASTIC) by Andwin Scientific