510(k) · Cleared
ClearedDynabite Hot GI Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portlyn Corp. · KGE Forceps, Biopsy, Electric
Cleared on Jun 17, 1997 after a 159-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jun 17, 1997
- Review
- 159 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK970083 Dynabite Hot GI Biopsy ForcepsPortlyn Corp. · 1997
- Descendant · cites it directly · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- Descendant · 4 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
- Descendant · 5 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K014216Secca SystemCuron Medical, Inc. · 2002 · cites it directly5descendants
- K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 2 generations on3descendants
- K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 3 generations on2descendants
- K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 4 generations on1descendant
- K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970083 | Dynabite Hot GI Biopsy Forceps | Portlyn Corp. | 1997 | — |
| +1 | K014216 | Secca System | Curon Medical, Inc. | 2002 | — |
| +2 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| +3 | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
| +4 | K140422 | Het Systems, LLC, Het Bipolar Ligator System | Het Systems, LLC | 2014 | — |
| +5 | K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Covidien, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | — | MicroVasive Hot Biopsy Forceps Named without a submission number | |
| * | — | Hot Biopsy Forceps Named without a submission number | |
| * | — | DynaBite GI Biopsy Forceps (non-electric) Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014216 | Secca System | 2002 | 5 |
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, K014216 (Curon Medical, Inc., 2002) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DynaBite HOT Biopsy Forceps is intended for uses in a gastrointestinal endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery.
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/K970083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970083: Dynabite Hot GI 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/K970083
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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