510(k) · Cleared
ClearedCaptura® Disposable Hot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · KGE Forceps, Biopsy, Electric
Cleared on Mar 21, 2018 as substantially equivalent to K923470 (Wilson-Cook Medical, Inc., 1993) after a 264-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Mar 21, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923470 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923470 Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc. · 1993
- This deviceK171973 Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923470 | Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | 1993 | — |
| 0 (this device) | K171973 | Captura® Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | 2018 | — |
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? (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 |
|---|---|---|---|
| * | K923470 | Disposable Hot Biopsy ForcepsSummary page 4…ce Class: Class II Review Panel: Gastroenterology-Urology Predicate Device Name: Disposable Hot Biopsy Forceps 510(k) Number: K923470 Date: Cleared April 21, 1993 Device Description The Captura® Disposable Hot Biopsy Forceps is a sterile, single… | 1993 |
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.
- 1 other device also cites its predicate K923470.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical
current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for
adult use only.
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/K171973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171973: Captura® Disposable Hot Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171973
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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