Endoscopic Video Image Processor, Single-Use Video Hysteroscope— 510(k) K232003
Substantially EquivalentGuangzhou Red Pine Medical Instrument Co., Ltd.
FDA 510(k) clearance K232003 for Endoscopic Video Image Processor, Single-Use Video Hysteroscope, Substantially Equivalent on 2024-02-12. Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Product code
- Code HIH
- Device class
- Class 2
- Regulation
- 21 CFR 884.1690
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code HIH
view all- K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- K253020 — Strauss Surgical Resection Instruments
- K254050 — Manual Tissue Removal Device
- K254251 — InnovexView (GC146-17, GC150-20, GC155-23)
More clearances from Guangzhou Red Pine Medical Instrument Co., Ltd.
view all- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3) +2 more
- K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F)
- K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Adverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.