510(k) · Cleared
Recalled · Class II · 2018The Espiner Sac or E Sac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espiner Medical Limited · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 26, 2011 as substantially equivalent to K982073 (Anchor Products Co., 1998) after an 89-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 26, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982073 (1998). 5 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK982073 Anchor Laparoscopic Tissue Retrieval SystemAnchor Products Co. · 1998
- This deviceK111845 The Espiner Sac or E SacEspiner Medical Limited · 2011
- Descendant · cites it directly · 0 of its ownK251743 SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen…Surgical Principals, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK200053 DANNIK Specimen Retrieval System with deployment mechanism, DANNIK…Dannik · 2020
- Descendant · cites it directly · 0 of its ownK181791 Simplystrong, SimplyezeeGenicon, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK180114 AEON Retrieval BagLexington Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK151489 Retrieval bag systemBeacon Surgical, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K251743SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval SystemSurgical Principals, Inc. · 2025 · cites it directly0descendants
- K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval…Dannik · 2020 · cites it directly0descendants
- K181791Simplystrong, SimplyezeeGenicon, Inc. · 2018 · cites it directly0descendants
- K180114AEON Retrieval BagLexington Medical, Inc. · 2018 · cites it directly0descendants
- K151489Retrieval bag systemBeacon Surgical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982073 | Anchor Laparoscopic Tissue Retrieval System | Anchor Products Co. | 1998 | — |
| 0 (this device) | K111845 | The Espiner Sac or E Sac | Espiner Medical Limited | 2011 | — |
| +1 | K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | 2025 | — |
| +1 | K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen… | Dannik | 2020 | — |
| +1 | K181791 | Simplystrong, Simplyezee | Genicon, Inc. | 2018 | — |
| +1 | K180114 | AEON Retrieval Bag | Lexington Medical, Inc. | 2018 | — |
| +1 | K151489 | Retrieval bag system | Beacon Surgical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K982073 | Anchor Laparoscopic Tissue Retrieval SystemSummary page 3…510O(k) Summary Summary of Substantial Equivalence: The predicate device family is the same product (not similar but identical) already approved with a 510(k) (K982073). Espiner Medical Ltd is the original manufacturer of the product family that is currently approved and being distributed inthe U… | 1998 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | 2025 | 0 |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval… | 2020 | 0 |
| K181791 | Simplystrong, Simplyezee | 2018 | 0 |
| K180114 | AEON Retrieval Bag | 2018 | 0 |
| K151489 | Retrieval bag system | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2018 | Class II | Z-0444-2019 | Error in labeling | Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml |
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. 2011, 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 Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111845: The Espiner Sac or E Sac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111845
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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