510(k) · Cleared
ClearedReprocessed Reloadable Cutters, Staplers, and Appliers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearmedical, Inc. · NLL Staple, Implantable, Reprocessed
Cleared on Jul 11, 2005 as substantially equivalent to K020779 (Ethicon Endo-Surgery, Inc., 2002) after a 606-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Jul 11, 2005
- Review
- 606 days
- Class
- Class II
- Product code
- NLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K821994 (1982). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
- 2 generations backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- 1 generation backK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
- This deviceK033578 Reprocessed Reloadable Cutters, Staplers, and AppliersClearmedical, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821994 | Disposable Linear Stapler-(LSR) | ETHICON, Inc. | 1982 | — |
| −2 | K980023 | Endopath and Proximate Linear Cutters | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −1 | K020779 | Proximate and Endopath Linear Cutters and Staplers | Ethicon Endo-Surgery, Inc. | 2002 | 17 |
| 0 (this device) | K033578 | Reprocessed Reloadable Cutters, Staplers, and Appliers | Clearmedical, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
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 NLL? 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 |
|---|---|---|---|
| * | K020779 | Proximate and Endopath Linear Cutters and StaplersSummary page 1…ication name: Manual surgical instrument for general use (21 CFR 878.4800) Product code: GCJ - Laparoscope, General & Plastic Surgery Predicate device: K020779 - Endopath and Proximate Linear Cutters and Staplers Device description: The Reprocessed Reloadable Cutters deliver two doubl… | 2002 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 19 other devices also cite its predicate K020779.
How does its category compare?
All NLL devicesNLL Staple, Implantable, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLL
2in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NLL
Too few NLL 510(k)s in any year since 2007 to give a median.
Recalls per year · NLL
No recall names NLL since 2007.
Adverse event reports per year · NLL
2in 2017
MAUDE reports naming product code NLL, 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 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 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 ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.
The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033578: Reprocessed Reloadable Cutters, Staplers, and Appliers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033578
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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