510(k) Report

510(k) · Cleared

Cleared

Manual Surgical Insrument

K951589510(k) TraditionalCleared May 3, 199527-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

United States Surgical, A Division of Tyco Healthc · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 3, 1995 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it.

Decided
May 3, 1995
Review
27 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

75 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 4 descendants cleared2003: 1 descendant cleared2008: 2 descendants cleared2014: 6 descendants cleared2021: 6 descendants cleared2013: 3 descendants cleared2020: 4 descendants cleared2012: 3 descendants cleared2011: 4 descendants cleared2010: 1 descendant cleared2017: 3 descendants cleared2016: 3 descendants cleared2023: 7 descendants cleared2015: 2 descendants cleared2024: 8 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2026: 3 descendants cleared2025: 8 descendants cleared1995200020052010201520202025
  1. This deviceK951589 Manual Surgical InsrumentUnited States Surgical, A Division of Tyco Healthc · 1995
  2. Descendant · cites it directly · 59 of its ownK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
  3. Descendant · 2 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  4. Descendant · cites it directly · 52 of its ownK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
  5. Descendant · 3 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
  6. Descendant · 3 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2003: 12008: 22009: 42010: 12011: 42012: 32013: 32014: 62015: 22016: 32017: 32018: 32019: 22020: 42021: 62022: 22023: 72024: 82025: 82026: 3
2003high 8 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 75 · See all
  • K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien · 2008 · cites it directly59descendants
  • K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · 2 generations on58descendants
  • K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009 · cites it directly52descendants
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · 3 generations on46descendants
  • K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · 3 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951589Manual Surgical InsrumentUnited States Surgical, A Division of Tyco Healthc1995—
+1K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…Covidien2008—
+2K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
+1K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States2009—
+3K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…Transenterix, Inc.20091
+3K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200820
200940
201010
201140
201230
201330
201460
201520
201630
201730
201830
201920
202040
202160
202220
202370
202480
202580
202630
FIG. 1 — Lineage of K951589, 1995–2026Source: 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (75)

See all 75

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien200859
K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States200952
K140662Flex Endoscopic InstrumentsDesign Standards Corp.20140
K090309Lagis Endoscopic InstrumentsLagis Enterprises Co, Ltd.20090
K031869Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and AccessoriesSurgical Instruments Service and Savings, Inc.20030

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, K072814 (Covidien, 2008) has gone furthest, with 59 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

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The GEI category page

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https://510kreport.com/device/K951589 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951589: Manual Surgical Insrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951589

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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