510(k) · Cleared
ClearedSingle Use Hot Biopsy Forceps FD-231
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · KGE Forceps, Biopsy, Electric
Cleared on Oct 13, 2017 as substantially equivalent to K993041 (The Olympus Optical Co., 2000) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Oct 13, 2017
- Review
- 109 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K790071 (1979). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790071 | Endoscope and Accessories | Olympus Corp. | 1979 | 6 |
| −1 | K983811 | Unipolar Optical Biopsy Forceps | Olympus Winter & Ibe GmbH | 1998 | — |
| 0 (this device) | K171916 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 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 KGE? 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 KGE device
- #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K993041 | Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary EquipmentSummary page 5…-7C-1 Hot Biopsy Forceps Olympus Unipolar Optical Biopsy Forceps K number K993041* K983811 (OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPH… | 2000 |
| * | K983811 | Unipolar Optical Biopsy ForcepsSummary page 5…ympus Unipolar Optical Biopsy Forceps K number K993041* K983811 (OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBE RSCOPE ACCESSORIE… | 1998 |
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?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K993041.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, 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 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171916: Single Use Hot Biopsy Forceps FD-231.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171916
Report an extraction error
Are you the manufacturer?
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