510(k) · Cleared
ClearedHenke Sass Wolf of America Bariatric Laparoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henke Sass Wolf of America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 24, 2005 as substantially equivalent to K941967 (Henke-Sass, Wolf GmbH, 1994) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Mar 24, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941967 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK941967 HSW Laparoscope and AccessoriesHenke-Sass, Wolf GmbH · 1994
- This deviceK050163 Henke Sass Wolf of America Bariatric LaparoscopeHenke Sass Wolf of America, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK201198 S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes…Smith & Nephew · 2020
Most influential descendants
Showing 1 of 1 · See all- K201198S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, AutoclavableSmith & Nephew · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941967 | HSW Laparoscope and Accessories | Henke-Sass, Wolf GmbH | 1994 | — |
| 0 (this device) | K050163 | Henke Sass Wolf of America Bariatric Laparoscope | Henke Sass Wolf of America, Inc. | 2005 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K941967 | HSW Laparoscope and AccessoriesSummary page 1…his device. Substantial Equivalence: The Henke Sass Wolf of America Bariatric Laparoscopes are substantially equivalent to the Henke Sass Wolf GmbH - K941967 and the Stryker - K993045 in design, materials, methods of construction and intended use. The intended use of the d… | 1994 |
| * | K993045 | Bariatric Laparoscope, Model 367Summary page 1…quivalence: The Henke Sass Wolf of America Bariatric Laparoscopes are substantially equivalent to the Henke Sass Wolf GmbH - K941967 and the Stryker - K993045 in design, materials, methods of construction and intended use. The intended use of the devices to which we claim substan… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | 2020 | 0 |
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?
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 Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures…
Read the full statement (117 words)
The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver.
Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050163: Henke Sass Wolf of America Bariatric Laparoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050163
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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