510(k) · Cleared
ClearedEndoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes, 10MM Diameter, 50 Degrees
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GCM Endoscope, Rigid
Cleared on Dec 10, 1999 after an 85-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Dec 10, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- GCM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK993103 Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30…Richard Wolf Medical Instruments Corp. · 1999
- Descendant · cites it directly · 2 of its ownK203226 Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM /…Richard Wolf Medical Instruments Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK260414 “Tech-Image” Video Endoscope SystemTech-Image CO., LTD. · 2026
- Descendant · 2 generations on · 0 of its ownK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
Most influential descendants
Showing 3 of 3 · See all- K203226Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…Richard Wolf Medical Instruments Corporation · 2021 · cites it directly2descendants
- K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD. · 2026 · 2 generations on0descendants
- K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993103 | Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees… | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +1 | K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O… | Richard Wolf Medical Instruments Corporation | 2021 | — |
| +2 | K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026 | — |
| +2 | K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL… | 2021 | 2 |
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?
- Of its descendants, K203226 (Richard Wolf Medical Instruments Corporation, 2021) has gone furthest, with 2 descendants of its own.
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 endoscopes serve to visualize the inside of the patient via natural or surgically generated access.
For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used aczessories in various medical disciplines, such as surgery, urology, gynecology, and ENT.
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/K993103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993103: Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes, 10MM Diameter, 50 Degrees.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993103
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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