OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13— 510(k) K060243
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K060243 for OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13, Substantially Equivalent on 2006-06-23. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code EOQ
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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)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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 →
Recalls naming K060243
K-number listed on FDA's recall record- Z-1071-2025 — Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
- Z-0970-2021 — K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-0971-2021 — K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-0972-2021 — K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-0973-2021 — K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-1050-2021 — K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-1051-2021 — K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-1052-2021 — K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Z-1053-2021 — K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060243.
Data sourced from openFDA. This site is unofficial and independent of the FDA.