510(k) Report

510(k) · Cleared

Cleared

Electrosurgical Hemostatic Forceps Series

K062517510(k) TraditionalCleared Dec 22, 2006116-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Olympus Medical Systems Corporation · KGE Forceps, Biopsy, Electric

Cleared on Dec 22, 2006 as substantially equivalent to K955052 (Olympus America, Inc., 1996) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it.

Decided
Dec 22, 2006
Review
116 days
Class
Class II
Product code
KGE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K955052 (1996). 2 ancestors in all. 10 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2023: 1 descendant cleared2025: 1 descendant cleared2016: 2 descendants cleared2021: 2 descendants cleared2010: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant clearedK955052 · Olympus FD-1/2-1 Hot Biopsy Forceps · Olympus America, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K955052 · Olympus FD-1/2-1 Hot Biopsy Forceps · Olympus America, Inc. · 19960
  1. Root · 1 generation backK955052 Olympus FD-1/2-1 Hot Biopsy ForcepsOlympus America, Inc. · 1996
  2. This deviceK062517 Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation · 2006
  3. Descendant · cites it directly · 3 of its ownK151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter…Fujifilm Medical System U.S.A., Inc. · 2016
  4. Descendant · 2 generations on · 2 of its ownK161186 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic…Fujifilm Medical Systems U.S.A, Inc. · 2016
  5. Descendant · cites it directly · 1 of its ownK202438 Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2021
  6. Descendant · 3 generations on · 1 of its ownK171096 Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. · 2017
  7. Descendant · 2 generations on · 0 of its ownK251807 Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR…Olympus Medical Systems Corp. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2010: 12016: 22017: 12021: 22022: 12023: 12025: 12026: 1
2010high 2 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 10 · See all
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016 · cites it directly3descendants
  • K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. · 2016 · 2 generations on2descendants
  • K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2021 · cites it directly1descendant
  • K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. · 2017 · 3 generations on1descendant
  • K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955052Olympus FD-1/2-1 Hot Biopsy ForcepsOlympus America, Inc.1996—
0 (this device)K062517Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation2006—
+1K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc.2016—
+2K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter…Fujifilm Medical Systems U.S.A, Inc.2016—
+1K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd.2021—
+3K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc.2017—
+2K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201620
201710
202120
202210
202310
202510
202610
FIG. 1 — Lineage of K062517, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K955052Olympus FD-1/2-1 Hot Biopsy Forceps
Summary page 2
…=== 3 Predicate Device Information Device Name Common Name 510(k) No. Manufacturer FD-1 L/U-1 Hot Biopsy Hot Biopsy K955052 Olympus Medical Systems Corp. Forceps Forceps LSVP International Hot Biopsy K971204…
Olympus America, Inc.1996—
*K971204LSVP International Hot Biopsy Forceps
Summary page 2
…L/U-1 Hot Biopsy Hot Biopsy K955052 Olympus Medical Systems Corp. Forceps Forceps LSVP International Hot Biopsy K971204 LSVP International. Inc. Hot Biopsy Forceps Forceps 4 Device Description The FD-1L/U-1 has been 510(k) cleare…
Lsvp Intl., Inc.1997—

Also cleared against K955052: 1 other device →

What descends from it? (10)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc.20163
K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd.20211
K242857ClearHemograsperFinemedix Co., Ltd.20250
K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.20230
K210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.20210
K091259Ethicon Endo-Surgery Flexible Bipolar Hemostasis ForcepsEthicon Endo-Surgery, Inc.20100

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, K151474 (Fujifilm Medical System U.S.A., Inc., 2016) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K955052.

How does its category compare?

All KGE devices

KGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGE

2in 2025

2009: 22010: 12013: 12014: 12016: 32017: 22018: 32019: 12021: 22022: 12023: 12025: 22026 (partial year): 1
2007high 3 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGE

184in 2018

2016: 102 days median2018: 184 days median
2007high 184 (2018) · low 102 (2016)2026

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

2007: 42008: 152009: 752010: 292011: 512012: 302013: 142014: 122015: 152016: 92017: 262018: 262019: 152020: 72021: 242022: 162023: 82024: 92025: 10
2007high 75 (2009) · low 4 (2007)2025

MAUDE reports naming product code KGE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20080—015
20092—075
20101—029
20110—051
20120—030
20131—014
20141—012
20150—015
2016310209
20172—026
20183184026
20191—015
20200—07
20212—024
20221—016
20231—08
20240—09
20252—010
20261—0—

What is it indicated for?

FD-1L/U-1 Hot Biopsy Forceps

This instrument has been designed to be used with Olympus endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

FD-41OLR Single Use Electrosurpical Hemostatic Forceps

This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

Indications for use as stated in the FDA summary.

Also cleared against K955052

1 other device cites the same predicate.

  • K101657Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps…Boston Scientific Corp · 2010

More from Olympus Medical Systems Corporation

86 FDA decisions under this applicant name. See the company

  • K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
  • K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation · 2026
  • K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation · 2026
  • K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation · 2026
  • K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation · 2026

Recent decisions in KGE

The KGE category page

  • K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp. · 2026
  • K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems Corporation · 2025
  • K242857ClearHemograsperFinemedix Co., Ltd. · 2025
  • K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd. · 2023
  • K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation · 2022

https://510kreport.com/device/K062517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062517: Electrosurgical Hemostatic Forceps Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062517

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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