510(k) · Cleared
ClearedSPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Principals, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 22, 2025 as substantially equivalent to K111845 (Espiner Medical Limited, 2011) after a 108-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Sep 22, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982073 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK982073 Anchor Laparoscopic Tissue Retrieval SystemAnchor Products Co. · 1998
- 1 generation backK111845 The Espiner Sac or E SacEspiner Medical Limited · 2011 · Recalled
- This deviceK251743 SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen…Surgical Principals, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982073 | Anchor Laparoscopic Tissue Retrieval System | Anchor Products Co. | 1998 | — |
| −1 | K111845 | The Espiner Sac or E Sac | Espiner Medical Limited | 2011 | 1 |
| 0 (this device) | K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K111845 | The Espiner Sac or E SacSummary page 5…™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval Systems claim Substantial Equivalence to the Espiner Tissue Retrieval System (Sac or E-Sac) under 510(k) K111845. 4. DEVICE DESCRIPTION The SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval Systems are sterile sing… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K111845.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 LaproSac TM Specimen Retrieval Bags is indicated for use in surgical procedures to capture
organs or tissue to be removed from the body cavity during Laparoscopic Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251743: SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251743
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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