510(k) · Cleared
ClearedPatton Endo-Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patton Medical Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 20, 2001 as substantially equivalent to K933104 (ETHICON, Inc., 1993) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Sep 20, 2001
- Review
- 72 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923945 (1993). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK923945 Pleatman Sac Specimen ContainerCabot Medical Corp. · 1993 · Recalled
- This deviceK012150 Patton Endo-BagPatton Medical Corp. · 2001
- Descendant · cites it directly · 3 of its ownK030422 Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003
- Descendant · 2 generations on · 2 of its ownK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- Descendant · 3 generations on · 1 of its ownK123728 Retrieval BagFlexbar Machine Corp. · 2013
- Descendant · 4 generations on · 0 of its ownK210248 Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K030422Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003 · cites it directly3descendants
- K033842Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of TissueVernon-Carus Limited · 2004 · 2 generations on2descendants
- K123728Retrieval BagFlexbar Machine Corp. · 2013 · 3 generations on1descendant
- K210248Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923945 | Pleatman Sac Specimen Container | Cabot Medical Corp. | 1993 | 1 |
| 0 (this device) | K012150 | Patton Endo-Bag | Patton Medical Corp. | 2001 | — |
| +1 | K030422 | Lina-Bag, Models LB-60, LB-100 | Lina Medical Cml Aps | 2003 | — |
| +2 | K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | Vernon-Carus Limited | 2004 | — |
| +3 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| +4 | K210248 | Lab Bag with Fabric Pouch | Advanced Medical Design Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K933104 | One-Handed Endopouch Specimen Retrieval BagSummary page 1…: Laparoscopic Specimen Retrieval System Classification: Laparoscope, General & Plastic Surgery, § 876.1500, Class i Predicate Devices: ENDOPOUCH SPECIMEN RETRIEVAL BAG (K933104), manufactured by Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876. PLEATMAN SAC SPECIMEN CONTAINER (K923945) manufactured by C… | 1993 |
| * | K923945 | Pleatman Sac Specimen ContainerSummary page 1…ass i Predicate Devices: ENDOPOUCH SPECIMEN RETRIEVAL BAG (K933104), manufactured by Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876. PLEATMAN SAC SPECIMEN CONTAINER (K923945) manufactured by Cabot Medical Corp., 2021 Cabot Bivd. West, Langhorne, PA 19047. Description of Device: The Patton Endo-Bag™ i… | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030422 | Lina-Bag, Models LB-60, LB-100 | 2003 | 3 |
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Patton Endo-Bag is a single-use retrieval bag designed to temporarily contain ergans or tissues and facilitates their removal from the patient without ~contamination, during laparoscopic surgery.
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/K012150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012150: Patton Endo-Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012150
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026