510(k) · Cleared
ClearedMsi Medserv International-Rigid Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Msi Medserv International Deutschland GmbH · GCM Endoscope, Rigid
Cleared on Sep 28, 2009 as substantially equivalent to K950076 (Olympus America, Inc., 1995) after a 278-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 28, 2009
- Review
- 278 days
- Class
- Class II
- Product code
- GCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950076 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950076 LaparoscopeOlympus America, Inc. · 1995
- This deviceK083840 Msi Medserv International-Rigid EndoscopeMsi Medserv International Deutschland GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950076 | Laparoscope | Olympus America, Inc. | 1995 | — |
| 0 (this device) | K083840 | Msi Medserv International-Rigid Endoscope | Msi Medserv International Deutschland GmbH | 2009 | — |
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 GCM? 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 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? (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 |
|---|---|---|---|
| * | K950076 | LaparoscopeSummary page 4…opes and accessories Proprietary Name MS1 MedServinternational : Rigid endoscopes Name of Predicate Predicate Device 510 (k) Reference No. Device Olympus America Inc. | K950076 Device Description A rigid endoscope is a tubular endoscopic device with any of a group of accessory devices which attach to the… | 1995 |
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.
- 2 other devices also cite its predicate K950076.
How does its category compare?
All GCM devicesGCM Endoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
MSI MedServ International Deutschland GmbH rigid endoscopes and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals.
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/K083840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083840: Msi Medserv International-Rigid Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083840
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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