510(k) Report

510(k) · Cleared

Cleared

Starion Instruments Power Point Cautery Grasper/Dissector

K002547510(k) TraditionalCleared Oct 20, 200064-day reviewClass II21 CFR 886.4115

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

Starion Instruments · HQP Unit, Cautery, Thermal, Battery-Powered

Cleared on Oct 20, 2000 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 20, 2000
Review
64 days
Class
Class II
Product code
HQP
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK002547 Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000
  2. Descendant · cites it directly · 2 of its ownK062257 Starion Instruments Thermal Litigating ShearsStarion Instruments · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK124029 Microline Flexible Ligating ShearsMicroline Surgical, Inc. · 2013
  4. Descendant · 2 generations on · 0 of its ownK122086 Thermal Ligating ShearsMicroline Surgical, Inc. · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K062257Starion Instruments Thermal Litigating ShearsStarion Instruments · 2006 · cites it directly2descendants
  • K124029Microline Flexible Ligating ShearsMicroline Surgical, Inc. · 2013 · 2 generations on0descendants
  • K122086Thermal Ligating ShearsMicroline Surgical, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments2000—
+1K062257Starion Instruments Thermal Litigating ShearsStarion Instruments20063
+2K124029Microline Flexible Ligating ShearsMicroline Surgical, Inc.2013—
+2K122086Thermal Ligating ShearsMicroline Surgical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201210
201310
FIG. 1 — Lineage of K002547, 2000–2013Source: 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 HQP? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K062257Starion Instruments Thermal Litigating ShearsStarion Instruments20062

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, K062257 (Starion Instruments, 2006) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HQP devices

HQP Unit, Cautery, Thermal, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQP

1in 2012

2007: 12009: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQP

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

Recalls per year · HQP

No recall names HQP since 2007.

Adverse event reports per year · HQP

22in 2025

2008: 12009: 22010: 32013: 12016: 22017: 12018: 32019: 22020: 32021: 22022: 72023: 82024: 232025: 22
2007high 23 (2024) · low 0 (2007)2025

MAUDE reports naming product code HQP, 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
20071—00
20080—01
20091—02
20100—03
20110—00
20121—00
20130—01
20140—00
20150—00
20160—02
20170—01
20180—03
20190—02
20200—03
20210—02
20220—07
20230—08
20240—023
20250—022
20260—0—
Cite this page

510(k) Report. “K002547: Starion Instruments Power Point Cautery Grasper/Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002547

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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