510(k) · Cleared
ClearedFTRD System Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ovesco Endoscopy AG · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Jul 25, 2017 after a 124-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 25, 2017
- Review
- 124 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK170867 FTRD System SetOvesco Endoscopy AG · 2017
- Descendant · cites it directly · 1 of its ownK240274 PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation · 2024
- Descendant · cites it directly · 0 of its ownK253481 colonic FTRD Set (200.70); diagnostic FTRD Set (200.76)…Ovesco Endoscopy AG · 2026
- Descendant · 2 generations on · 0 of its ownK250842 PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K240274PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation · 2024 · cites it directly1descendant
- K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AG · 2026 · cites it directly0descendants
- K250842PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170867 | FTRD System Set | Ovesco Endoscopy AG | 2017 | — |
| +1 | K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2024 | — |
| +1 | K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD… | Ovesco Endoscopy AG | 2026 | — |
| +2 | K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PKL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PKL device
- #1 K202333 Lockado Repositionable Hemostasis Clipscore 17.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K240274 (STERIS Corporation, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PKL devicesPKL Hemostatic Metal Clip For The Gi Tract: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PKL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKL
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKL
1,170in 2025
MAUDE reports naming product code PKL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | 102 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 3 | 143 | 0 | 34 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 2 | — | 0 | 398 |
| 2018 | 5 | 116 | 0 | 393 |
| 2019 | 4 | 231 | 1 | 699 |
| 2020 | 6 | 164 | 0 | 504 |
| 2021 | 2 | — | 0 | 668 |
| 2022 | 9 | 259 | 0 | 522 |
| 2023 | 2 | — | 0 | 863 |
| 2024 | 8 | 181 | 0 | 1,216 |
| 2025 | 6 | 162 | 0 | 1,170 |
| 2026 | 7 | 231 | 0 | — |
What is it indicated for?
FTRD System:
Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum.
The FTRD System is indicated for the resection of lesions < 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis.
FTRD Marking Probe:
Instrument for marking tissue using superficial HF coagulation in flexible endoscopy.
FTRD Grasper:
Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the FTRD System.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K170867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170867: FTRD System Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026