510(k) · Cleared
ClearedTelescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL 305MM, Telescope 0 O 10MM WL 440MM / Telescope 30 O 10MM WL 440MM / Telescope 50 O 10MM WL 440MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corporation · GCM Endoscope, Rigid
Cleared on May 14, 2021 as substantially equivalent to K993103 (Richard Wolf Medical Instruments Corp., 1999) after a 193-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- May 14, 2021
- Review
- 193 days
- Class
- Class II
- Product code
- GCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993103 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993103 Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30…Richard Wolf Medical Instruments Corp. · 1999
- This deviceK203226 Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM /…Richard Wolf Medical Instruments Corporation · 2021
- Descendant · cites it directly · 0 of its ownK260414 “Tech-Image” Video Endoscope SystemTech-Image CO., LTD. · 2026
- Descendant · cites it directly · 0 of its ownK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993103 | Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees… | Richard Wolf Medical Instruments Corp. | 1999 | — |
| 0 (this device) | K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O… | Richard Wolf Medical Instruments Corporation | 2021 | — |
| +1 | K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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.
- 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 |
|---|---|---|---|
| * | K993103 | Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes…Summary page 5…8934.431 Endoscope 0° Ø 10MM 8934.432 Endoscope 30° Ø 10MM 8934.433 Endoscope 50° Ø 10MM 510(k) Number: K993103 Regulatory Class: II Product Code: GCJ, GCM, (KOG) Manufacturer: Richard Wolf GmbH The predic… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K260414 (Tech-Image CO., LTD., 2026) has gone furthest, with 0 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. 2021, 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?
The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203226: Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL 305MM, Telescope 0 O 10MM WL 440MM / Telescope 30 O 10MM WL 440MM / Telescope 50 O 10MM WL 440MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203226
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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