510(k) Report

510(k) · Cleared

Cleared

Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han

K932266510(k) TraditionalCleared Mar 15, 1994329-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

Symbiosis Corp. · KGE Forceps, Biopsy, Electric

Cleared on Mar 15, 1994 after a 329-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 15, 1994
Review
329 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 2002: 1 descendant cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK932266 Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanSymbiosis Corp. · 1994
  2. Descendant · cites it directly · 0 of its ownK033593 Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK022751 Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K033593Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc. · 2003 · cites it directly0descendants
  • K022751Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932266Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanSymbiosis Corp.1994—
+1K033593Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc.2003—
+1K022751Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
FIG. 1 — Lineage of K932266, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 lists a 510(k) statement for it but has not posted the file, 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
K033593Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc.20030
K022751Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services20020

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, K033593 (Clearmedical, Inc., 2003) 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—
Cite this page

510(k) Report. “K932266: Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932266

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026