510(k) · Cleared
ClearedMini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and Trocars 2 MM, Dilatation Sleeve and Guide Rod 2 MM to 3.M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Dec 12, 1997 as substantially equivalent to K932441 (Richard Wolf Medical Instruments Corp., 1994) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 12, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932441 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932441 Series 8920 Trocar SystemRichard Wolf Medical Instruments Corp. · 1994
- This deviceK973737 Mini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and…Richard Wolf Medical Instruments Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932441 | Series 8920 Trocar System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| 0 (this device) | K973737 | Mini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and Trocars 2 MM… | Richard Wolf Medical Instruments Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K932441 | Series 8920 Trocar SystemSummary page 1…on Name: Trocar sleeves and trocars rocar 5 lO(k) Number Trade or proprietary or modei name Manufacturer 1 pre-enact. 1 Trocar sleeve with trocar 4940AB 1 Richard Wolf 2 K932441 2 Trocar system 8920.xxx 2 Richard Wolf 3 K942201 3 Laparoscopy dilation system 8934.xxx,... {3 Richard Wolf 4 4 Trocars and thre… | 1994 |
| * | K942201 | Laparoscopy Dilation SystemSummary page 1…Number Trade or proprietary or modei name Manufacturer 1 pre-enact. 1 Trocar sleeve with trocar 4940AB 1 Richard Wolf 2 K932441 2 Trocar system 8920.xxx 2 Richard Wolf 3 K942201 3 Laparoscopy dilation system 8934.xxx,... {3 Richard Wolf 4 4 Trocars and thread sleeve 4 Karl Storz 5 5 Trocars/ cannulas syste… | 1994 |
| * | — | Trocar sleeve with trocar Named without a submission number | |
| * | — | Trocars and thread sleeve Named without a submission number | |
| * | — | Trocars/cannulas systems Named without a submission number |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The trocar sleeves and trocars serve to gain access to body cavities. The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters. For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists. There are…
Read the full statement (133 words)
The trocar sleeves and trocars serve to gain access to body cavities.
The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters.
For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists.
There are currently no known contraindications relating directly to the product. The physician should decide whether or not the planned application can be performed based on the of the patient’s general condition.
The trocar sleeves and trocars are used in with insufflators, reducing adapters, reducing sleeves, extraction sleeves, dilation sleeves, guide rods, threaded fixation sleeves, sliding cones and, endoscopes, as well as endoscopic accessories (e.g. forceps, electrodes).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973737 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973737: Mini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and Trocars 2 MM, Dilatation Sleeve and Guide Rod 2 MM to 3.M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973737
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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