Disposable Distal Attachment D-201-13404— 510(k) K260856
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K260856 for Disposable Distal Attachment D-201-13404, Substantially Equivalent on 2026-08-27. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Summary
The Disposable Distal Attachment D-201-13404 is an Olympus Medical Systems submission under product code FDS, flexible or rigid gastroscopes and accessories. The record doesn't describe the attachment beyond its name.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Olympus filed from Hachioji-Shi, Japan. FDA found it substantially equivalent 164 calendar days after receipt (March 16 to August 27, 2026).
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Product code FDS
- 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 FDS
view allMore clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K250993 — Single Use Cytology Brush V (BC-V600P-3010)
Adverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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.