510(k) · Cleared
ClearedReprocessed Autosuture Gia Endoscopic Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLL Staple, Implantable, Reprocessed
Cleared on Oct 18, 2007 as substantially equivalent to K061095 (United States Surgical, A Division of Tyco Healthc, 2006) after a 198-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Oct 18, 2007
- Review
- 198 days
- Class
- Class II
- Product code
- NLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061095 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK061095 Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
- This deviceK070930 Reprocessed Autosuture Gia Endoscopic StaplersSterilmed, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061095 | Auto Sutur Endo Gia Staplers | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| 0 (this device) | K070930 | Reprocessed Autosuture Gia Endoscopic Staplers | Sterilmed, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K061095 | Auto Sutur Endo Gia StaplersSummary page 1…Predicate iThe reproc's]sed AutoSurure (GIA [ndoscopic Staplers are substantially equivalent to the Desvices: AutoSuture GIA Endoseopic Stapler (K06 1095). De,. ice SterilMed's reprocessed AutoSuture CIA Endoscopic Stapler places two triple staggered rowes Description… | 2006 |
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 no recall.
- 6 other devices also cite its predicate K061095.
How does its category compare?
All NLL devicesNLL Staple, Implantable, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection and resection of liver tissue, hepatic vasculature and biliary structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070930: Reprocessed Autosuture Gia Endoscopic Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070930
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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