Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) +2 more— 510(k) K250210

Clearance details

Device name as filed

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

Applicant

Scivita Medical Technology Co., Ltd.

Product code

Code EOQ

Device class

Class 2

Regulation

21 CFR 874.4680

Advisory panel

Ear, Nose, Throat

Date received

2025-01-24

Decision date

2025-03-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Suzhou, CN

• K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more2026-09-02
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• K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
• K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14

• K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)2026-08-14
• K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more2026-01-20
• K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P +2 more2025-03-27
• K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)2024-10-23
• K240192 — Single-use Extraction Baskets2024-10-15

Death

135

Injury

2,863

Malfunction

21,662

Total

24,660

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 →