Cyclo-Brush
510(k) K870782
Cyclo-Brush is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K870782 on 18 May 1987, active as of 10 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 | NumberK870782 | Date18 May 1987 | StatusActive |
Official records
- FDA 510(k) database K870782
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- Withdrawn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
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Other devices filed under FDA product code HHT (Spatula, Cervical, Cytological).
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- PURITAN FOAM TIP SWAB MODEL 2197 by Hardwood Products Co., LP
- SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 by MEDICAL ACTION INDUSTRIES INC.
- GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT by Gynetech, Inc.
- CYTOLOGY BRUSHES by Medical Packaging Corporation
- PAP-PAK CYTOBRUSH KIT by Medical Packaging Corporation
- CERVEX-BRUSH by Unimar, Inc.