Home › Device types › HET
Laparoscope, Gynecologic (And Accessories)
FDA product code HET · Class 2 · Obstetrics/Gynecology
2,593
Registered devices
16,889
Adverse events
19
Recalls
338
510(k) clearances
Devices with this code
Integra® MicroFrance® — INTEGRA MICROFRANCEIntegra® MicroFrance® — INTEGRA MICROFRANCEIntegra® MicroFrance® — INTEGRA MICROFRANCEIntegra® MicroFrance® — INTEGRA MICROFRANCEStandard Grasper, 35cm with RR Handle — ENCISION, INC.Integra® MicroFrance® — INTEGRA MICROFRANCEIntegra® MicroFrance® — INTEGRA MICROFRANCEIntegra® MicroFrance® — INTEGRA MICROFRANCEOlympus — OLYMPUS Winter & Ibe GmbHOlympus — OLYMPUS Winter & Ibe GmbHSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Integra® MicroFrance® — INTEGRA MICROFRANCEn.a. — Karl Storz GmbH & Co. KGSymmetry Surgical® — ASPEN SURGICAL PRODUCTS, INC.PAD/CHAM — APPLIED MEDICAL RESOURCES CORPORATIONSuction and irrigation Pump for Laparoscopy — W.O.M. World of Medicine GmbHCNGL3 - ALBRECHT — APPLIED MEDICAL RESOURCES CORPORATIONSymmetry Surgical® — ASPEN SURGICAL PRODUCTS, INC.ELMED — ELMED INCORPORATEDEndoplus — EndoplusEndoplus — EndoplusMedline — MEDLINE INDUSTRIES, INC.4K UHD Laparoscope — Scivita Medical Technology Co., Ltd.Endoplus — Endoplus
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for |
| 2023-11-06 | Olympus Corporation of the Americas | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surger |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if use |
| 2022-02-23 | Carefusion 2200 Inc | The finished device package did not contain the IFU. |
| 2017-02-10 | Olympus Corporation of the Americas | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
| 2015-11-17 | Olympus Corporation of the Americas | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in pati |
| 2014-07-16 | Market-Tiers Inc | Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. |
| 2009-09-28 | Ethicon, Inc. | There is the potential for the duckbill seal to become dislodged. |
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