510(k) · Cleared
ClearedReveel Endoscopic Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retraction Limited · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 11, 2014 as substantially equivalent to K123110 (Surgical Innovations Plc, 2013) and 2 other predicates after a 163-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Apr 11, 2014
- Review
- 163 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914190 (1992). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914190 Auto Suture (R) Endoscopic Fan RetractorUnited States Surgical, A Division of Tyco Healthc · 1992
- This deviceK133345 Reveel Endoscopic RetractorRetraction Limited · 2014
- Descendant · cites it directly · 1 of its ownK162445 LiVac Retractor SystemLivac Pty, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK243399 Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914190 | Auto Suture (R) Endoscopic Fan Retractor | United States Surgical, A Division of Tyco Healthc | 1992 | — |
| 0 (this device) | K133345 | Reveel Endoscopic Retractor | Retraction Limited | 2014 | — |
| +1 | K162445 | LiVac Retractor System | Livac Pty, Ltd. | 2016 | — |
| +2 | K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K123110 | Pretzelflex Surgical Retractor Model SHR7301Summary page 1…VICES PRETZELFLEX Surgical Innovations "PRETZELFLEX" Limited (K(123110) AUTO SUTURE ENDO United States Surgical "ENDO RETRACT HI" RETRACT II (… | 2013 |
| * | K914190 | Auto Suture (R) Endoscopic Fan RetractorSummary page 1…AUTO SUTURE ENDO United States Surgical "ENDO RETRACT HI" RETRACT II (Covidien) (K(914190) RETRACTOR Automated Medical "NATHANiSON" Produc… | 1992 |
| * | K942002 | RetractorSummary page 1…RETRACTOR Automated Medical "NATHANiSON" Products Corp. (K(942002) K13 3345… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162445 | LiVac Retractor System | 2016 | 1 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K162445 (Livac Pty, Ltd., 2016) has gone furthest, with 1 descendant 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. 2014, 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?
REVEEL is designed as an organ and tissue retractor for the use in endloscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133345: Reveel Endoscopic Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133345
Report an extraction error
Are you the manufacturer?
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