Panels › Gastroenterology, Urology › Product code OCT · Class 2
Anti Fog Solution And Accessories, Endoscopy
Regulation 876.1500
0510(k)s in 12 months (27 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in OCT
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries, Inc. | 1 | 1 |
| Minimally Invasive Devices, LLC | 2 | 0 |
| Advanced Medical Design Co., Ltd. | 1 | 0 |
| Anago, Inc. | 1 | 0 |
| Batrik Medical Manufacturing, Inc. | 1 | 0 |
| Deroyal Industries, Inc. | 1 | 0 |
| Eagle Medical Intl. | 1 | 0 |
| Highpoint Medical Corp. | 1 | 0 |
| Inman Liebelt Corp. | 1 | 0 |
| Jdi Surgical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2022 | Sunstar Americas, Inc. BUTLER Clear Dip, 12 bottles/case Terminated |
OCT | None listed |
| Jul 18, 2019 | Medline Industries, Inc. Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, Open, Classified |
OCT | K982465 |
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