K935070 is an FDA 510(k) clearance for the GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS. This device is classified as a Forceps, Biopsy, Non-electric (Class I - General Controls, product code FCL).
Submitted by KARL STORZ Endoscopy-America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on January 25, 1994, 92 days after receiving the submission on October 25, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K935070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1993 |
| Decision Date | January 25, 1994 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1075 |