510(k) Report

510(k) · Cleared

Cleared

Coagulator Cutter, Endoscopic Bipolar and Accessories

K943776510(k) TraditionalCleared Nov 3, 199493-day reviewClass II21 CFR 884.4150

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

Richard Wolf Medical Instruments Corp. · HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Cleared on Nov 3, 1994 after a 93-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Nov 3, 1994
Review
93 days
Class
Class II
Product code
HIN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK943776 Coagulator Cutter, Endoscopic Bipolar and AccessoriesRichard Wolf Medical Instruments Corp. · 1994
  2. Descendant · cites it directly · 0 of its ownK983236 Bipolar HF CableRichard Wolf Medical Instruments Corp. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K983236Bipolar HF CableRichard Wolf Medical Instruments Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943776Coagulator Cutter, Endoscopic Bipolar and AccessoriesRichard Wolf Medical Instruments Corp.1994—
+1K983236Bipolar HF CableRichard Wolf Medical Instruments Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K943776, 1994–1998Source: 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 HIN? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K983236Bipolar HF CableRichard Wolf Medical Instruments Corp.19980

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, K983236 (Richard Wolf Medical Instruments Corp., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HIN devices

HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIN

1in 2014

2011: 22012: 22013: 22014: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIN

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

Recalls per year · HIN

No recall names HIN since 2007.

Adverse event reports per year · HIN

43in 2025

2009: 62010: 72011: 62012: 12013: 142014: 122015: 82016: 22017: 82018: 22019: 42020: 92021: 102022: 12023: 92024: 292025: 43
2007high 43 (2025) · low 0 (2007)2025

MAUDE reports naming product code HIN, 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—00
20080—00
20090—06
20100—07
20112—06
20122—01
20132—014
20141—012
20150—08
20160—02
20170—08
20180—02
20190—04
20200—09
20210—010
20220—01
20230—09
20240—029
20250—043
20260—0—

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

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  • K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in HIN

The HIN category page

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  • K122983Ksea Bipolar ElectrodeKARL STORZ Endoscopy-America, Inc. · 2013
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https://510kreport.com/device/K943776 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943776: Coagulator Cutter, Endoscopic Bipolar and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943776

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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