510(k) · Cleared
Recalled · Class II · 2015Surgical Tissue Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · KGY Bag, Intestine
Cleared on Mar 28, 1991 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled once.
- Decided
- Mar 28, 1991
- Review
- 23 days
- Class
- Class I
- Product code
- KGY
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK910914 Surgical Tissue PouchCook Urological, Inc. · 1991
- Descendant · cites it directly · 5 of its ownK142427 Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014
- Descendant · 2 generations on · 1 of its ownK211043 Alexis Contained Extraction SystemApplied Medical Resources Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK211234 RedExAdvanced Surgical Concepts, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK150781 Tissue Removal PouchBoehringer Laboratories, LLC · 2015
- Descendant · cites it directly · 1 of its ownK013872 Rusch Memory BagRusch Intl. · 2002
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142427Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014 · cites it directly5descendants
- K211043Alexis Contained Extraction SystemApplied Medical Resources Corporation · 2022 · 2 generations on1descendant
- K211234RedExAdvanced Surgical Concepts, Ltd. · 2021 · 2 generations on1descendant
- K150781Tissue Removal PouchBoehringer Laboratories, LLC · 2015 · 2 generations on1descendant
- K013872Rusch Memory BagRusch Intl. · 2002 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910914 | Surgical Tissue Pouch | Cook Urological, Inc. | 1991 | — |
| +1 | K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources | 2014 | — |
| +2 | K211043 | Alexis Contained Extraction System | Applied Medical Resources Corporation | 2022 | — |
| +2 | K211234 | RedEx | Advanced Surgical Concepts, Ltd. | 2021 | — |
| +2 | K150781 | Tissue Removal Pouch | Boehringer Laboratories, LLC | 2015 | — |
| +1 | K013872 | Rusch Memory Bag | Rusch Intl. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 KGY? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2015 | Class II | Z-1830-2015 | Labeling Change Control | Includes Information not stated in the intended use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142427 (Applied Medical Resources, 2014) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KGY devicesKGY Bag, Intestine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGY
FDA has decided no KGY device since 2007.
Median 510(k) review, days · KGY
Too few KGY 510(k)s in any year since 2007 to give a median.
Recalls per year · KGY
No recall names KGY since 2007.
Adverse event reports per year · KGY
14in 2025
MAUDE reports naming product code KGY, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910914: Surgical Tissue Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910914
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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