510(k) Report

510(k) · Cleared

Cleared

Reprocessed Used Disposable Hot and Cold Biopsy Forceps

K022751510(k) TraditionalCleared Nov 4, 200277-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

Medical Device Services · KGE Forceps, Biopsy, Electric

Cleared on Nov 4, 2002 as substantially equivalent to K932266 (Symbiosis Corp., 1994) after a 77-day review. Its family tree reaches back 1 generation to 1994.

Decided
Nov 4, 2002
Review
77 days
Class
Class II
Product code
KGE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K932266 (1994). No later device cites it as a predicate yet.

K932266 · Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han · Symbiosis Corp. · 199419901992199419961998200020022004
  1. Root · 1 generation backK932266 Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanSymbiosis Corp. · 1994
  2. This deviceK022751 Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K932266Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanSymbiosis Corp.1994—
0 (this device)K022751Reprocessed Used Disposable Hot and Cold Biopsy ForcepsMedical Device Services2002—
FIG. 1 — Lineage of K022751, 1994–2002Source: 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), 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? (1)

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
*K932266Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han
Summary page 1
…vices, Reprocessed Used Disposable Biopsy Forceps are substantially equivalent to disposable biopsy fbrceps currently marketed new by Microvasive under 5 10(k) 932266. Public Health Service…
Symbiosis Corp.1994—

Also cleared against K932266: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K932266.

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?

Medical Device Services (MDS) intends to reprocess used disposable hot and cold biopsy forceps manufactured by Microvasive.

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract

Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

MDS reprocessed biopsy forceps are disposable unless reprocessed again by MDS

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K022751: Reprocessed Used Disposable Hot and Cold Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022751

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026