510(k) · Cleared
ClearedTissue Removal Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Laboratories, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 19, 2015 as substantially equivalent to K142427 (Applied Medical Resources, 2014) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Jun 19, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910914 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910914 Surgical Tissue PouchCook Urological, Inc. · 1991 · Recalled
- 1 generation backK142427 Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014
- This deviceK150781 Tissue Removal PouchBoehringer Laboratories, LLC · 2015
- Descendant · cites it directly · 0 of its ownK151990 Tissue Removal SystemBoehringer Laboratories, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K151990Tissue Removal SystemBoehringer Laboratories, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910914 | Surgical Tissue Pouch | Cook Urological, Inc. | 1991 | 1 |
| −1 | K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources | 2014 | — |
| 0 (this device) | K150781 | Tissue Removal Pouch | Boehringer Laboratories, LLC | 2015 | — |
| +1 | K151990 | Tissue Removal System | Boehringer Laboratories, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K142427 | Tissue Containment System; 10, 14, 17, 25Summary page 4…and Accessories Classification Panel: General & Plastic Surgery PREDICATE DEVICES: Primary Predicate: Applied Medical Tissue Containment System K142427 Additional Predicate: Applied Medical Specimen Retrieval System K060051 DEVICE DESCRIPTION: The Tissue Remo… | 2014 |
| * | K060051 | Specimen Retrieval SystemSummary page 4…Predicate: Applied Medical Tissue Containment System K142427 Additional Predicate: Applied Medical Specimen Retrieval System K060051 DEVICE DESCRIPTION: The Tissue Removal Pouch includes a polymer film bag, a flip ring packaged in two halves, and a guard. It is… | 2006 |
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 |
|---|---|---|---|
| K151990 | Tissue Removal System | 2015 | 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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 23.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K151990 (Boehringer Laboratories, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142427.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.
Contraindications:
The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Removal Pouch is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
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/K150781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150781: Tissue Removal Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150781
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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