Home › Device types › FCW
Light Source, Fiberoptic, Routine
FDA product code FCW · Class 2 · Gastroenterology, Urology
265
Registered devices
2,996
Adverse events
5
Recalls
31
510(k) clearances
Devices with this code
n.a. — Karl Storz GmbH & Co. KGTSI — TEDAN SURGICAL INNOVATIONS, L.L.C.n.a. — Karl Storz GmbH & Co. KGSunoptic Technologies — SUNOPTIC TECHNOLOGIES LLCn.a. — Karl Storz GmbH & Co. KGASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONSunoptic Technologies — SUNOPTIC TECHNOLOGIES LLCn.a. — Karl Storz GmbH & Co. KGN/A — SCHÖLLY FIBEROPTIC GmbHn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGInnomed, Inc. — INNOMED, INC.I-Tek I-150 LED Light Source — I-Tek Medical, Inc.NA — STRYKER CORPORATIONSunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer — SUNOPTIC TECHNOLOGIES LLCIntegra® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONn.a. — Karl Storz GmbH & Co. KGN/A — PENTAX OF AMERICA, INC.n.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGPUREVUE — Medos International SàrlASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONn.a. — Karl Storz GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-02 | Stryker Corporation | Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being conv |
| 2011-10-14 | Integra LifeSciences Corp. | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| 2011-10-14 | Integra LifeSciences Corp. | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| 2011-10-14 | Integra LifeSciences Corp. | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| 2011-03-07 | Integra LifeSciences Corp. | Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down. |
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