Submission Details
| 510(k) Number | K141057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 2014 |
| Decision Date | May 14, 2015 |
| Days to Decision | 385 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
DISPOSABLE CERVICAL BRUSH
May 2015
Decision
385d
Days
Class 2
Risk
About This 510(k) Submission
K141057 is an FDA 510(k) clearance for the DISPOSABLE CERVICAL BRUSH, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Ningbo Hls Medical Products Co., Ltd. (Dover, US). The FDA issued a Cleared decision on May 14, 2015, 385 days after receiving the submission on April 24, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
Device Classification
| Product Code | HHT — Spatula, Cervical, Cytological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
Manufacturer
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