RESECTOSCOPE SHEATH— 510(k) K931995
Substantially EquivalentOlympus Corp.
FDA 510(k) clearance K931995 for RESECTOSCOPE SHEATH, Substantially Equivalent on 1993-07-23. Applicant: Olympus Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Corp.
- Product code
- Code FJL
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Success, NY, US
Recent devices under product code FJL
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More clearances from Olympus Corp.
view allAdverse events under product code FJL
product code FJL- Death
- 2
- Total
- 2
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 K931995
K-number listed on FDA's recall record- Z-1438-2026 — Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
- Z-1439-2026 — Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
- Z-1440-2026 — Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
- Z-1441-2026 — Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
- Z-1442-2026 — Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
- Z-1443-2026 — Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
- Z-1444-2026 — Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
- Z-1445-2026 — Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
- Z-1446-2026 — Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
- Z-1447-2026 — Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
- Z-1448-2026 — Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
- Z-1450-2026 — Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
- Z-1451-2026 — Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
- Z-1452-2026 — Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
- Z-1453-2026 — Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
- Z-1455-2026 — Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Z-1456-2026 — Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
- Z-1457-2026 — Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K931995.
Data sourced from openFDA. This site is unofficial and independent of the FDA.