510(k) · Cleared
ClearedS+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 17, 2020 as substantially equivalent to K941541 (Henke Sass Wolf of America, Inc., 1994) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jul 17, 2020
- Review
- 74 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941967 (1994). 4 ancestors in all, the oldest K941541 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK941967 HSW Laparoscope and AccessoriesHenke-Sass, Wolf GmbH · 1994
- 1 generation backK050163 Henke Sass Wolf of America Bariatric LaparoscopeHenke Sass Wolf of America, Inc. · 2005
- This deviceK201198 S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes…Smith & Nephew · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941967 | HSW Laparoscope and Accessories | Henke-Sass, Wolf GmbH | 1994 | — |
| −1 | K050163 | Henke Sass Wolf of America Bariatric Laparoscope | Henke Sass Wolf of America, Inc. | 2005 | — |
| 0 (this device) | K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO… | Smith & Nephew | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K941541 | HSV Laparoscopy SetSummary page 5…use and fundamental scientific technology to the following legally marketed devices in commercial distribution: Henke Sass Wolf Laparoscopes and Laparoscopes cleared in K941541 (Laparoscopes) and K050163 (Bariatric Laparoscopes). K201198 E. Dev… | 1994 |
| * | K050163 | Henke Sass Wolf of America Bariatric LaparoscopeSummary page 5…fic technology to the following legally marketed devices in commercial distribution: Henke Sass Wolf Laparoscopes and Laparoscopes cleared in K941541 (Laparoscopes) and K050163 (Bariatric Laparoscopes). K201198 E. Device Description The propose… | 2005 |
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 26 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K941541.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Smith & Nephew Laparoscopes are indicated for use in illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and Liver.
Smith & Nephew Bariatric Laparoscopes are indicated for illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and Liver.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201198: S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201198
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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