510(k) · Cleared
ClearedSkin Staple Extractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAG Stapler, Surgical
Cleared on Nov 3, 1976 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 3, 1976
- Review
- 36 days
- Class
- Class II
- Product code
- GAG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK760733 Skin Staple ExtractorETHICON, Inc. · 1976
- Descendant · cites it directly · 2 of its ownK955748 Doyle ExtractorSafetech Intl., Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK973497 HuberlocMedcare Medical Group, Inc. · 1998
- Descendant · 3 generations on · 0 of its ownK021916 Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K760733 | Skin Staple Extractor | ETHICON, Inc. | 1976 | — |
| +1 | K955748 | Doyle Extractor | Safetech Intl., Inc. | 1996 | — |
| +2 | K973497 | Huberloc | Medcare Medical Group, Inc. | 1998 | — |
| +3 | K021916 | Harmac Huber Needle Safety Device, H2984001 | Harmac Medical Products, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAG? 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 GAG device
- #1 K241629 ECHELON 3000 45mm Compact Stapler (ECH45C)…score 15.7 · 8 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K955748 | Doyle Extractor | 1996 | 2 |
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, K955748 (Safetech Intl., Inc., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GAG devicesGAG Stapler, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAG
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAG
1,065in 2025
MAUDE reports naming product code GAG, 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 | 919 |
| 2008 | 0 | — | 0 | 366 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 0 | — | 1 | 22 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 49 |
| 2013 | 0 | — | 0 | 135 |
| 2014 | 0 | — | 0 | 302 |
| 2015 | 0 | — | 0 | 144 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 96 |
| 2018 | 0 | — | 1 | 81 |
| 2019 | 0 | — | 0 | 70 |
| 2020 | 0 | — | 0 | 47 |
| 2021 | 0 | — | 0 | 53 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 4 | 102 | 0 | 109 |
| 2024 | 3 | 138 | 0 | 1,126 |
| 2025 | 2 | — | 0 | 1,065 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K760733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K760733: Skin Staple Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760733
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026