510(k) Report

510(k) · Cleared

Cleared

Bipolar Forceps

K792365510(k) TraditionalCleared Dec 10, 197917-day reviewClass II21 CFR 878.4400

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

Concept, Inc. · JOS Electrode, Electrosurgical

Cleared on Dec 10, 1979 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Dec 10, 1979
Review
17 days
Class
Class II
Product code
JOS
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2021: 1 descendant cleared2008: 1 descendant cleared2015: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared19801990200020102020
  1. This deviceK792365 Bipolar ForcepsConcept, Inc. · 1979
  2. Descendant · cites it directly · 10 of its ownK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK150959 Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015
  4. Descendant · 3 generations on · 2 of its ownK172368 Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018
  5. Descendant · 2 generations on · 2 of its ownK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
  6. Descendant · 2 generations on · 1 of its ownK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12004: 12008: 12010: 12015: 12018: 12021: 12023: 12024: 12026: 1
1999high 1 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 11 · See all
  • K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · cites it directly10descendants
  • K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015 · 2 generations on3descendants
  • K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018 · 3 generations on2descendants
  • K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 2003 · 2 generations on2descendants
  • K080257Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K792365Bipolar ForcepsConcept, Inc.1979—
+1K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc.19992
+2K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH2015—
+3K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH2018—
+2K024304Microsurgical Bipolar HandpieceNeomedix Corp.2003—
+2K080257Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200410
200810
201010
201510
201810
202110
202310
202410
202610
FIG. 1 — Lineage of K792365, 1979–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc.199910

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, K993655 (Xomed, Inc., 1999) has gone furthest, with 10 descendants of its own.

How does its category compare?

All JOS devices

JOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOS

Too few JOS 510(k)s in any year since 2007 to give a median.

Recalls per year · JOS

2in 2019

2008: 12012: 22016: 12019: 2
2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOS

6in 2025

2007: 292008: 372009: 622010: 142011: 52012: 72013: 52014: 72015: 132016: 62017: 72018: 102019: 172020: 122021: 52022: 82023: 92024: 32025: 6
2007high 62 (2009) · low 3 (2024)2025

MAUDE reports naming product code JOS, 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—029
20080—137
20090—062
20100—014
20110—05
20120—27
20130—05
20140—07
20150—013
20161—16
20170—07
20180—010
20190—217
20200—012
20210—05
20220—08
20230—09
20240—03
20250—06
20260—0—
Cite this page

510(k) Report. “K792365: Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K792365

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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