Transformer, Endoscope
FDA product code GCW · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
1510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K771864 | Wall Transformers 74710 & 74910GCW · Traditional | Welch Allyn, Inc. | 11/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2745-2017 Class II | 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically…Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C… | Pentax of America Inc | 04/13/2017Terminated |
| Z-2744-2017 Class II | 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record…Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C… | Pentax of America Inc | 04/13/2017Terminated |
| Z-2743-2017 Class II | 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically…Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C… | Pentax of America Inc | 04/13/2017Terminated |
| Z-2742-2017 Class II | 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E…Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C… | Pentax of America Inc | 04/13/2017Terminated |
| Z-2219-2015 Class II | Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2217-2015 Class II | Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm -…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |