SINGLE USE REPOSITIONABLE CLIP— 510(k) K123601
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K123601 for SINGLE USE REPOSITIONABLE CLIP, Substantially Equivalent on 2013-04-29. 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
- Center Valley, PA, US
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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 →
Recalls naming K123601
K-number listed on FDA's recall record- Z-1987-2023 — Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
- Z-1988-2023 — Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
- Z-1989-2023 — Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
- Z-1990-2023 — Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123601.
Data sourced from openFDA. This site is unofficial and independent of the FDA.