510(k) · Cleared
ClearedDegall Laparoscopic Gallbladder Extractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicon, Inc. · GCI Laryngoscope, Endoscope
Cleared on Aug 15, 2002 after a 79-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 15, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- GCI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK021747 Degall Laparoscopic Gallbladder ExtractorSurgicon, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK033359 Degall II Gallbladder ExtractorSurgicon, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033359Degall II Gallbladder ExtractorSurgicon, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021747 | Degall Laparoscopic Gallbladder Extractor | Surgicon, Inc. | 2002 | — |
| +1 | K033359 | Degall II Gallbladder Extractor | Surgicon, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 GCI? 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? (2)
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 |
|---|---|---|---|
| * | — | Auto Suture Endo Catch Specimen Pouch Named without a submission number | |
| * | — | Minogue Xtractor Specimen Retrieval Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033359 | Degall II Gallbladder Extractor | 2003 | 0 |
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, K033359 (Surgicon, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCI devicesGCI Laryngoscope, Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCI
FDA has decided no GCI device since 2007.
Median 510(k) review, days · GCI
Too few GCI 510(k)s in any year since 2007 to give a median.
Recalls per year · GCI
No recall names GCI since 2007.
Adverse event reports per year · GCI
121in 2025
MAUDE reports naming product code GCI, 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 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 49 |
| 2012 | 0 | — | 0 | 55 |
| 2013 | 0 | — | 0 | 50 |
| 2014 | 0 | — | 0 | 106 |
| 2015 | 0 | — | 0 | 177 |
| 2016 | 0 | — | 0 | 100 |
| 2017 | 0 | — | 0 | 130 |
| 2018 | 0 | — | 0 | 102 |
| 2019 | 0 | — | 0 | 135 |
| 2020 | 0 | — | 0 | 129 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 102 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 119 |
| 2025 | 0 | — | 0 | 121 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021747 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021747: Degall Laparoscopic Gallbladder Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021747
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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