510(k) · Cleared
ClearedEndoscope Introducer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsubishi Cable America, Inc. · FDE Laparoscopy Kit
Cleared on Apr 18, 1996 as substantially equivalent to K912443 (Candela Laser Corp., 1991) after a 122-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Apr 18, 1996
- Review
- 122 days
- Class
- Class II
- Product code
- FDE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912443 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912443 Candela Introducer Sheath SystemCandela Laser Corp. · 1991
- This deviceK955717 Endoscope Introducer KitMitsubishi Cable America, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912443 | Candela Introducer Sheath System | Candela Laser Corp. | 1991 | — |
| 0 (this device) | K955717 | Endoscope Introducer Kit | Mitsubishi Cable America, Inc. | 1996 | — |
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 FDE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K912443 | Candela Introducer Sheath SystemSummary page 1…ndoscope Introducer Kit is substantially equivalent to the ‘Candela Introducer Sheath System” that was approved by FDA for marketing on August 16, 1991, under 510(k) No. K912443. Description of Device: The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommoda… | 1991 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FDE devicesFDE Laparoscopy Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDE
FDA has decided no FDE device since 2007.
Median 510(k) review, days · FDE
Too few FDE 510(k)s in any year since 2007 to give a median.
Recalls per year · FDE
3in 2025
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FDE
17in 2025
MAUDE reports naming product code FDE, 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 | 5 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 18 (18) | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 1 | 14 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 17 |
| 2023 | 0 | — | 4 | 23 |
| 2024 | 0 | — | 7 | 56 |
| 2025 | 0 | — | 3 (1) | 17 |
| 2026 | 0 | — | 16 | — |
What is it indicated for?
The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.
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/K955717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955717: Endoscope Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955717
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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