Home › Device types › FAS
Electrode, Electrosurgical, Active, Urological
FDA product code FAS · Class 2 · Gastroenterology, Urology
1,183
Registered devices
2,372
Adverse events
9
Recalls
58
510(k) clearances
Devices with this code
Greenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.Electrode — SOPRO-COMEG GmbHSHARK/S-LINE — Richard Wolf GmbHsalinetrode Bipolar RF Electrode — PROSURG INCNA — STRYKER CORPORATIONE-LINE — Richard Wolf GmbHSHARK/S-LINE — Richard Wolf GmbHNA — STRYKER CORPORATIONSHARK/S-LINE — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGNA — STRYKER CORPORATIONAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.ProMax™ Series Bard® Max-Blade™ Coagulating Resector — C. R. Bard, Inc.Signature Series — PROSURG INCSHARK — Richard Wolf GmbHOlympus — OLYMPUS Winter & Ibe GmbHAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Dornier MedTech — DORNIER MEDTECH AMERICA, INC.NA — STRYKER CORPORATIONGreenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.Bipolar HF cable — SOPRO-COMEG GmbHNA — STRYKER CORPORATIONOlympus — OLYMPUS Winter & Ibe GmbHn.a. — Karl Storz GmbH & Co. KG
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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