Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip— 510(k) K183590
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K183590 for Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip, Substantially Equivalent on 2019-08-01. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code PKL
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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Adverse events under product code PKL
product code PKL- Death
- 9
- Injury
- 489
- Malfunction
- 4,698
- Other
- 1
- Total
- 5,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.