510(k) · Cleared
ClearedKsea Set for Endoscopic Assisted Intubation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCM Endoscope, Rigid
Cleared on Sep 17, 1996 after an 89-day review. The FDA summary names no predicate by number.
- Decided
- Sep 17, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- GCM
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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.
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Top candidate predicates for a new GCM device
- #1 K203226 Telescope 0 O 10MM WL 305MM / Telescope 30 O…score 7.3 · 1 generation · no Class I recall
What was it cleared against?
The FDA summary names no predicate by 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.
How does its category compare?
All GCM devicesGCM Endoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCM
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · GCM
Too few GCM 510(k)s in any year since 2007 to give a median.
Recalls per year · GCM
No recall names GCM since 2007.
Adverse event reports per year · GCM
607in 2025
MAUDE reports naming product code GCM, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 449 |
| 2025 | 0 | — | 0 | 607 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.
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/K962393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962393: Ksea Set for Endoscopic Assisted Intubation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026