510(k) · Cleared
ClearedRadial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps Box 40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KGE Forceps, Biopsy, Electric
Cleared on Oct 5, 2010 as substantially equivalent to K910964 (Symbiosis Corp., 1991) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Oct 5, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910964 (1991). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK910964 Hot Biopsy ForcepsSymbiosis Corp. · 1991
- This deviceK101657 Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps…Boston Scientific Corp · 2010
- Descendant · cites it directly · 1 of its ownK212423 EndoDrill® Model XBibbinstruments AB · 2023
- Descendant · cites it directly · 0 of its ownK250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy…Olympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK231422 Precision GILimaca Medical, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK131991 Endochoice Hot Biopsy ForcepsEndochoice, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K212423EndoDrill® Model XBibbinstruments AB · 2023 · cites it directly1descendant
- K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K231422Precision GILimaca Medical, Ltd. · 2023 · 2 generations on0descendants
- K131991Endochoice Hot Biopsy ForcepsEndochoice, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910964 | Hot Biopsy Forceps | Symbiosis Corp. | 1991 | — |
| 0 (this device) | K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20… | Boston Scientific Corp | 2010 | — |
| +1 | K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023 | — |
| +1 | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K231422 | Precision GI | Limaca Medical, Ltd. | 2023 | — |
| +1 | K131991 | Endochoice Hot Biopsy Forceps | Endochoice, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K910964 | Hot Biopsy ForcepsSummary page 2…The proposed Radial JawTm 4 Hot Biopsy Forceps are nearly identical in design, materials, and manufacturing processes to the predicate Radial Jaw~h Hot Biopsy Forceps (K9 10964), Radial JawTM 3 Hot Biopsy Forceps (K910964) and the Olympus Disposable Hot biopsy Forceps (K955052). 7. Performance Data: Ben… | 1991 |
| * | K955052 | Olympus FD-1/2-1 Hot Biopsy ForcepsSummary page 2…cturing processes to the predicate Radial Jaw~h Hot Biopsy Forceps (K9 10964), Radial JawTM 3 Hot Biopsy Forceps (K910964) and the Olympus Disposable Hot biopsy Forceps (K955052). 7. Performance Data: Bench testing and Electrical Safety Testing have been performed on the finished Radial JawTm 4 Hot Biops… | 1996 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K212423 (Bibbinstruments AB, 2023) has gone furthest, with 1 descendant 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. 2010, 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?
These Single-Use Biopsy Forceps are intended to be used through an endoscope to cauterize polyps and/or tissue specimens throughout the alimentary tract. The alimentary tract include the esophagus, stomach, duodenum, jejunum, ileum, and colon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101657: Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps Box 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101657
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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