Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
FDA 510(k) clearance K241987 · decided 2024-08-02
Clearance details
- K-number
- K241987
- Device name
- Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-08
- Decision date
- 2024-08-02
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Guangzhou Red Pine Medical Instrument Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.