Submission Details
| 510(k) Number | K250263 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 29, 2025 |
| Decision Date | March 31, 2025 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
Disposable Grasping Forceps FG-52D/FG-54D
Mar 2025
Decision
61d
Days
Class 2
Risk
About This 510(k) Submission
K250263 is an FDA 510(k) clearance for the Disposable Grasping Forceps FG-52D/FG-54D, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on March 31, 2025, 61 days after receiving the submission on January 29, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.
Device Classification
| Product Code | KTI — Bronchoscope Accessory |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |
Manufacturer
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