510(k) · Cleared
Cleared14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symmetry Medical · ODY Tunneled Catheter Remover
Cleared on Sep 28, 2012 as substantially equivalent to K063048 (Tran Pa-C, Inc., 2007) after a 63-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Sep 28, 2012
- Review
- 63 days
- Class
- Class II
- Product code
- ODY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063048 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK063048 Trans-Catheter ExtractorTran Pa-C, Inc. · 2007 · Recalled
- This deviceK122263 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical…Symmetry Medical · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063048 | Trans-Catheter Extractor | Tran Pa-C, Inc. | 2007 | 1 |
| 0 (this device) | K122263 | 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use | Symmetry Medical | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063048 | Trans-Catheter ExtractorSummary page 1…. The cuffed catheter removal device's design does not alter the fundamental technology of the predicate device or the devices' intended use. K063048 - Trans Catheter Extractor 4. Device Description Symmetry Surgical Single Use Cuffed Catheter Removal devices are… | 2007 |
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.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All ODY devicesODY Tunneled Catheter Remover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ODY
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ODY
Too few ODY 510(k)s in any year since 2007 to give a median.
Recalls per year · ODY
No recall names ODY since 2007.
Adverse event reports per year · ODY
1in 2010
MAUDE reports naming product code ODY, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122263: 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122263
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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