K990334 is an FDA 510(k) clearance for the KSEA ENDOSCOPE HOLDER. This device is classified as a Endoscope Holder (Class II - Special Controls, product code OCV).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 22, 1999, 47 days after receiving the submission on February 3, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Hold Endoscope In A Desired Position During Procedures..
| 510(k) Number | K990334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1999 |
| Decision Date | March 22, 1999 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCV — Endoscope Holder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Hold Endoscope In A Desired Position During Procedures. |