510(k) · Cleared
ClearedHot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symbiosis Corp. · KGE Forceps, Biopsy, Electric
Cleared on May 2, 1991 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 2, 1991
- Review
- 57 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK910964 Hot Biopsy ForcepsSymbiosis Corp. · 1991
- Descendant · cites it directly · 4 of its ownK101657 Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps…Boston Scientific Corp · 2010
- Descendant · 2 generations on · 1 of its ownK212423 EndoDrill® Model XBibbinstruments AB · 2023
- Descendant · 2 generations on · 0 of its ownK250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy…Olympus Medical Systems Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK231422 Precision GILimaca Medical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK131991 Endochoice Hot Biopsy ForcepsEndochoice, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K101657Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4…Boston Scientific Corp · 2010 · cites it directly4descendants
- K212423EndoDrill® Model XBibbinstruments AB · 2023 · 2 generations on1descendant
- K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K231422Precision GILimaca Medical, Ltd. · 2023 · 3 generations on0descendants
- K131991Endochoice Hot Biopsy ForcepsEndochoice, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910964 | Hot Biopsy Forceps | Symbiosis Corp. | 1991 | — |
| +1 | K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20… | Boston Scientific Corp | 2010 | — |
| +2 | K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023 | — |
| +2 | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | 2025 | — |
| +3 | K231422 | Precision GI | Limaca Medical, Ltd. | 2023 | — |
| +2 | K131991 | Endochoice Hot Biopsy Forceps | Endochoice, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4… | 2010 | 4 |
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, K101657 (Boston Scientific Corp, 2010) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K910964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910964: 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/K910964
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026