510(k) · Cleared
Recalled · Class II · 2019Modification to Optical Separator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 14, 2004 as substantially equivalent to K032889 (Applied Medical Resources, 2003) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 14, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990028 (1999). 4 ancestors in all, the oldest K963359 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
- 1 generation backK032889 Optical SeparatorApplied Medical Resources · 2003
- This deviceK041795 Modification to Optical Separator SystemApplied Medical Resources Corp. · 2004
- Descendant · cites it directly · 0 of its ownK111002 Reprocessed Endoscopic TrocarsSterilmed, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK063788 Reprocessed Endoscopic Trocars and CannulasAscent Healthcare Solutions · 2007 · Recalled
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 |
|---|---|---|---|---|---|
| −2 | K990028 | Endopath Optiview Optical Surgical Obturator and Sleeve | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −1 | K032889 | Optical Separator | Applied Medical Resources | 2003 | — |
| 0 (this device) | K041795 | Modification to Optical Separator System | Applied Medical Resources Corp. | 2004 | — |
| +1 | K111002 | Reprocessed Endoscopic Trocars | Sterilmed, Inc. | 2011 | — |
| +1 | K063788 | Reprocessed Endoscopic Trocars and Cannulas | Ascent Healthcare Solutions | 2007 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K032889 | Optical SeparatorSummary page 1…Plastic Surgery (21CFR 876.1500) TRADE NAME: Optical Separator System PREDICATE DEVICE: Applied Medical Optical Separator (K032889) Applied Medical Insufflation Needle (K9633 59) Applied… | 2003 |
| * | K963359 | Insufflation NeedleSummary page 1…arator System PREDICATE DEVICE: Applied Medical Optical Separator (K032889) Applied Medical Insufflation Needle (K9633 59) Applied Medical, Rancho Santa Margarita, CA INTENDED USE: The Optical Separator System is… | 1996 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Jan 28, 2019 | Class II | Z-1959-2019 | Packaging | The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K111002 (Sterilmed, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032889.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Optical Separator System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041795: Modification to Optical Separator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041795
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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