510(k) Report

510(k) · Cleared

Cleared

Finesse Iec/601

K941251510(k) TraditionalCleared Dec 12, 1994272-day reviewClass II21 CFR 884.4120

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

Utah Medical Products, Inc. · HGI Electrocautery, Gynecologic (And Accessories)

Cleared on Dec 12, 1994 after a 272-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
Dec 12, 1994
Review
272 days
Class
Class II
Product code
HGI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK941251 Finesse Iec/601Utah Medical Products, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK123310 Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc. · 2013
  3. Descendant · 2 generations on · 0 of its ownK133273 Liger Medical Esu-110Liger Medical, LLC · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc. · 2013 · cites it directly1descendant
  • K133273Liger Medical Esu-110Liger Medical, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941251Finesse Iec/601Utah Medical Products, Inc.1994—
+1K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc.2013—
+2K133273Liger Medical Esu-110Liger Medical, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
FIG. 1 — Lineage of K941251, 1994–2014Source: 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 HGI? 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 HGI device

  1. #1 K202915 IRIS Thermocoagulator and Digital Colposcopescore 2.1 · 4 generations · no Class I recall
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)

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

NumberDeviceApplicantDecidedDescendants
K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc.20131

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, K123310 (Utah Medical Products, Inc., 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HGI devices

HGI Electrocautery, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGI

1in 2021

2007: 12012: 12014: 12016: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGI

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

Recalls per year · HGI

7in 2021

2012: 12014: 12019: 32021: 7
2007high 7 (2021) · low 0 (2007)2026

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

Adverse event reports per year · HGI

41in 2025

2008: 12009: 12010: 12011: 22013: 62014: 12015: 272016: 562017: 332018: 302019: 1272020: 1022021: 1002022: 1042023: 612024: 442025: 41
2007high 127 (2019) · low 0 (2007)2025

MAUDE reports naming product code HGI, 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
20090—01
20100—01
20110—02
20121—10
20130—06
20141—11
20150—027
20161—056
20170—033
20180—030
20190—3127
20200—0102
20211—7100
20220—0104
20230—061
20240—044
20250—041
20260—0—

More from Utah Medical Products, Inc.

38 FDA decisions under this applicant name. See the company

  • K143424Utah CVX-RipeUtah Medical Products, Inc. · 2015
  • K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc. · 2013
  • K101535BT-CathUtah Medical Products, Inc. · 2011
  • K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007
  • K001874Peripherally Inserted Central CatheterUtah Medical Products, Inc. · 2000

Recent decisions in HGI

The HGI category page

  • K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC · 2021
  • K152843Liger Medical HTU-110Liger Medical, LLC · 2016
  • K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
  • K121881Domain Surgical SystemDomain Surgical, Inc. · 2012
  • K070877Endocervical Electrode # 2Modern Medical Equipment Mfg., Ltd. · 2007

https://510kreport.com/device/K941251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941251: Finesse Iec/601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941251

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