510(k) · Cleared
Recalled · Class II · 2023Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCF Proctoscope
Cleared on Mar 6, 1995 after a 132-day review. The FDA summary names no predicate by number. It has been recalled once.
- Decided
- Mar 6, 1995
- Review
- 132 days
- Class
- Class II
- Product code
- GCF
- Recalls
- 1
- 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.
Planning a device in GCF? 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?
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2023 | Class II | Z-0571-2024 | Device Design | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GCF devicesGCF Proctoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCF
FDA has decided no GCF device since 2007.
Median 510(k) review, days · GCF
Too few GCF 510(k)s in any year since 2007 to give a median.
Recalls per year · GCF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCF
1in 2016
MAUDE reports naming product code GCF, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Karl Storz Endoscopy Proctoscopes, Sigmoidoscopes, Accessories, and Proctosigmoidoscopy Instruments are manually operated, reusable devices which are designed for use by qualified surgeons during gastroenterological endoscopic procedures.
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/K945209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945209: Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945209
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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