Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)— 510(k) K241987

Clearance details

Applicant

Guangzhou Red Pine Medical Instrument Co., Ltd.

Product code

Product code HIH

Device class

Class 2

Regulation

21 CFR 884.1690

Advisory panel

Obstetrics/Gynecology

Date received

2024-07-08

Decision date

2024-08-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Guangzhou, CN

• K254252 — UNIDRIVE SIII System +1 more2026-09-25
• K261102 — UNIDRIVE Select System2026-09-18
• 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)2026-09-08
• K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)2026-08-18
• K253020 — Strauss Surgical Resection Instruments2026-06-04

• K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)2026-09-09
• K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3) +2 more2025-12-16
• K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)2025-08-08
• K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F)2025-02-07
• K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)2024-07-12

Death

18

Injury

973

Malfunction

5,071

Other

1

Total

6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →