510(k) Report

510(k) · Cleared

Cleared

Disposable Hot Biopsy Forceps

K923470510(k) TraditionalCleared Apr 21, 1993281-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

Wilson-Cook Medical, Inc. · KGE Forceps, Biopsy, Electric

Cleared on Apr 21, 1993 after a 281-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 21, 1993
Review
281 days
Class
Class II
Product code
KGE
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK923470 Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK171973 Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc. · 2018
  3. Descendant · cites it directly · 0 of its ownK050136 Reprocessed Hot Biopsy ForcepsSterilmed, Inc. · 2005 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K171973Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc. · 2018 · cites it directly0descendants
  • K050136Reprocessed Hot Biopsy ForcepsSterilmed, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923470Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc.1993—
+1K171973Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc.2018—
+1K050136Reprocessed Hot Biopsy ForcepsSterilmed, Inc.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201810
FIG. 1 — Lineage of K923470, 1993–2018Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K171973Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc.20180
K050136Reprocessed Hot Biopsy ForcepsSterilmed, Inc.20050

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, K171973 (Wilson-Cook Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.

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—

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

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/K923470 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923470: Disposable 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/K923470

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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