HD Camera Head OLYMPUS CH-S200-08-LB— 510(k) K261260
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K261260 for HD Camera Head OLYMPUS CH-S200-08-LB, Substantially Equivalent on 2026-06-24. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Summary
Olympus Medical Systems' HD Camera Head (OLYMPUS CH-S200-08-LB) is filed under FET, endoscopic video imaging systems and components for gastroenterology and urology. The record doesn't describe the camera head beyond its name and the code name.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Olympus filed from Hachioji-Shi, Japan. Review took 69 calendar days (April 16 to June 24, 2026).
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Product code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
Recent devices under product code FET
view allMore clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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.