510(k) · Cleared
ClearedLina-Bag, Models LB-60, LB-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lina Medical Cml Aps · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 14, 2003 as substantially equivalent to K012150 (Patton Medical Corp., 2001) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Apr 14, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923945 (1993). 4 ancestors in all, the oldest K922123 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923945 Pleatman Sac Specimen ContainerCabot Medical Corp. · 1993 · Recalled
- 1 generation backK012150 Patton Endo-BagPatton Medical Corp. · 2001
- This deviceK030422 Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003
- Descendant · cites it directly · 2 of its ownK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- Descendant · 2 generations on · 1 of its ownK123728 Retrieval BagFlexbar Machine Corp. · 2013
- Descendant · 3 generations on · 0 of its ownK210248 Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K033842Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of TissueVernon-Carus Limited · 2004 · cites it directly2descendants
- K123728Retrieval BagFlexbar Machine Corp. · 2013 · 2 generations on1descendant
- K210248Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923945 | Pleatman Sac Specimen Container | Cabot Medical Corp. | 1993 | 1 |
| −1 | K012150 | Patton Endo-Bag | Patton Medical Corp. | 2001 | — |
| 0 (this device) | K030422 | Lina-Bag, Models LB-60, LB-100 | Lina Medical Cml Aps | 2003 | — |
| +1 | K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | Vernon-Carus Limited | 2004 | — |
| +2 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| +3 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K012150 | Patton Endo-Bag | 2001 |
| * | K933104 | One-Handed Endopouch Specimen Retrieval BagSummary page 1…, distributed by Patton Medical 1000 Westbank Drive, Suite 5A200, Austin, TX 78746 ENDOPOUCH Specimen Retrieval Bag (K933104), manufactured by Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876 Auto Sut… | 1993 |
| * | K922123 | Auto Suture Disposable Endoscopic Specimen PouchSummary page 1…Inc., P.O. Box 151, Somerville, NJ 08876 Auto Suture ENDO CATCH Single Use Specimen Pouch (K922123), manufactured by U.S. Surgical, Division of TYCO,150 Glover Ave., Norwalk, CT 06856 Description of De… | 1993 |
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 |
|---|---|---|---|
| K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | 2004 | 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K033842 (Vernon-Carus Limited, 2004) has gone furthest, with 2 descendants of its own.
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?
A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient witbout contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder. gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030422 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030422: Lina-Bag, Models LB-60, LB-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030422
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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