510(k) · Cleared
ClearedLSVP International Hot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsvp Intl., Inc. · KGE Forceps, Biopsy, Electric
Cleared on May 27, 1997 after a 56-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- May 27, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK971204 LSVP International Hot Biopsy ForcepsLsvp Intl., Inc. · 1997
- Descendant · cites it directly · 10 of its ownK062517 Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation · 2006
- Descendant · 2 generations on · 3 of its ownK151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter…Fujifilm Medical System U.S.A., Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK161186 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic…Fujifilm Medical Systems U.S.A, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK202438 Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2021
- Descendant · 4 generations on · 1 of its ownK171096 Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062517Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation · 2006 · cites it directly10descendants
- K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016 · 2 generations on3descendants
- K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. · 2016 · 3 generations on2descendants
- K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2021 · 2 generations on1descendant
- K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971204 | LSVP International Hot Biopsy Forceps | Lsvp Intl., Inc. | 1997 | — |
| +1 | K062517 | Electrosurgical Hemostatic Forceps Series | Olympus Medical Systems Corporation | 2006 | — |
| +2 | K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | Fujifilm Medical System U.S.A., Inc. | 2016 | — |
| +3 | K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter… | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| +2 | K202438 | Ensure Single-Use Coagulation Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
| +4 | K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | — | Reusable Hot Biopsy Forceps manufactured by Olympus Named without a submission number | |
| * | — | Reusable Hot Biopsy Forceps manufactured by Microvasive Corp. Named without a submission number | |
| * | — | Reusable Hot Biopsy Forceps manufactured by Fujinon, Inc. Named without a submission number | |
| * | — | Reusable Hot Biopsy Forceps manufactured by Mill-Rose Labs. Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062517 | Electrosurgical Hemostatic Forceps Series | 2006 | 10 |
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, K062517 (Olympus Medical Systems Corporation, 2006) has gone furthest, with 10 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 primary indication for hot biopsy forceps is simultaneous biopsy and coagulation of diminutive polyps.
Hot biopsy forceps are intended for use in conjunction with an electrocautery unit.
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/K971204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971204: LSVP International 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/K971204
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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