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 Oct 12, 2016 after a 306-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 12, 2016
- Review
- 306 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
No later submission names this one as a predicate yet.
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.
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. 2016, 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?
DTC Snare: The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5…
Read the full statement (152 words)
DTC Snare:
The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Bleeding ulcers
- Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon
- Closure of GI tract luminal perforations < 20 mm that can be treated conservatively
The snare is an instrument for flexible endoscopy for grasping and removing tissue in the gastrointestinal tract.
Marking Probe:
Instrument for marking tissue using superficial HF coagulation in flexible endoscopy.
Grasper:
Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the DTC Snare.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K153550 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153550: FTRD System Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153550
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026