Home › Device types › FAS
Electrode, Electrosurgical, Active, Urological
FDA product code FAS · Class 2 · Gastroenterology, Urology
1,216
Registered devices
2,428
Adverse events
9
Recalls
58
510(k) clearances
Devices with this code
Passive working element (SIDE load; round ; Fr22 ; STORZ compatible) — LAMIDEY NOURY MEDICALSignature Series — PROSURG INCUSA Elite — Gyrus ACMI, LLCUSA Elite — Gyrus ACMI, LLCNA — STRYKER CORPORATIONE-LINE — Richard Wolf GmbHElectrode — SOPRO-COMEG GmbHOlympus — OLYMPUS Winter & Ibe GmbHStrauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Salinetrode Bipolar RF Electrode — PROSURG INCAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Electrode — SOPRO-COMEG GmbHStrauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.Neoscope — PROSURG INCGreenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.ACE — ACE MEDICAL DEVICES PRIVATE LIMITEDMonopolar HF cable — SOPRO-COMEG GmbHn.a. — Karl Storz GmbH & Co. KGNA — STRYKER CORPORATIONNA — STRYKER CORPORATIONProMax™ Series Bard® V-Max™ Roller Bar — C. R. Bard, Inc.n.a. — Karl Storz GmbH & Co. KGPRINCESS — Richard Wolf GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-02 | Olympus Corporation of the Americas | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. |
| 2023-06-08 | Olympus Corporation of the Americas | Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact w |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2018-04-17 | Gyrus Acmi, Incorporated | There is a potential for the cord to spark and cause a fire. |
| 2016-11-03 | Olympus Corporation of the Americas | Software malfunction that results in incorrect generation or display of error codes. |
| 2016-10-12 | C.R. Bard, Inc. | Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. |
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