510(k) · Cleared
ClearedMicro-France Trocars and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jun 9, 2000 as substantially equivalent to K960299 (Richard Wolf Medical Instruments Corp., 1996) and 2 other predicates after a 224-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 9, 2000
- Review
- 224 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K960299 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960299 Pyramid Trocar, 10MM W/Spring Ret. Protective Sleeve or Trocar…Richard Wolf Medical Instruments Corp. · 1996
- This deviceK993653 Micro-France Trocars and AccessoriesXomed, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960299 | Pyramid Trocar, 10MM W/Spring Ret. Protective Sleeve or Trocar W/Spring Loaded… | Richard Wolf Medical Instruments Corp. | 1996 | — |
| 0 (this device) | K993653 | Micro-France Trocars and Accessories | Xomed, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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? (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 |
|---|---|---|---|
| * | K960299 | Pyramid Trocar, 10MM W/Spring Ret. Protective Sleeve or Trocar W/Spring Loaded…Summary page 2…opcock for insufflation. 023 8.0 Substantial Equivalence The trocars and accessories are substantially equivalent to devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045). 024 f o Nttny, o wancg, “ _ {é DEPARTMENT OF HE… | 1996 |
| * | K964450 | Secondary Trocar and Sleeve with Insufflation PortSummary page 2…023 8.0 Substantial Equivalence The trocars and accessories are substantially equivalent to devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045). 024 f o Nttny, o wancg, “ _ {é DEPARTMENT OF HEALTH & HUMAN SERVICES Pu… | 1997 |
| * | K965045 | Tristar LP Torcar with Low Profile Threaded SleeveSummary page 2…al Equivalence The trocars and accessories are substantially equivalent to devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045). 024 f o Nttny, o wancg, “ _ {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug A… | 1997 |
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 3 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 trocars and accessories are intended to establish and maintain surgical access to the abdominal or thoracic cavity for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation.
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/K993653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993653: Micro-France Trocars and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993653
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