Cervical Spatula
510(k) K811548
Cervical Spatula is a medical device (FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by Procedure Products, Inc., cleared under FDA 510(k) K811548 on 23 Jun 1981, 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 | NumberK811548 | Date23 Jun 1981 | StatusActive |
Official records
- FDA 510(k) database K811548
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- Withdrawn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).
- PAP-PAK CYTOBRUSH KIT by Medical Packaging Corporation
- CERVEX-BRUSH by Unimar, Inc.
- DETECT (TM) CYTOLOGY BRUSH by Cook Ob/Gyn
- ROCKET ENDOCERVICAL BRUSH by A & A Medical, Inc.
- SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT by Andwin Scientific
- CERVICAL BRUSH by Statlab Medical Products, Inc.
- ROCKET CERVICAL SPATULA by A & A Medical, Inc.
- Puritan Histobrush® 25-2188 by Puritan Medical Products Company
- C-E BRUSH by Surgipath Medical Industries, Inc.
- Puritan Histobrush Cytology Brush 2199 by Puritan Medical Products Company