510(k) Report

510(k) · Cleared

Cleared

ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)

K234147510(k) TraditionalCleared Apr 23, 2024116-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

Microline Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 23, 2024 as substantially equivalent to K201884 (Microline Surgical, Inc., 2020) after a 116-day review. Its family tree reaches back 3 generations to 1993.

Decided
Apr 23, 2024
Review
116 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K932648 (1993). No later device cites it as a predicate yet.

K932648 · Quick Switch Laparoscopic Instruments · Microline Pentax, Inc. · 1993K962119 · RE-New Laparoscopic Instruments · Microline Pentax, Inc. · 1996 · recalledK201884 · ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm · Microline Surgical, Inc. · 202019901995200020052010201520202025
K201884 · ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm · Microline Surgical, Inc. · 2020K962119 · RE-New Laparoscopic Instruments · Microline Pentax, Inc. · 1996 · recalledK932648 · Quick Switch Laparoscopic Instruments · Microline Pentax, Inc. · 19930
  1. Root · 3 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
  2. 2 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
  3. 1 generation backK201884 ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece…Microline Surgical, Inc. · 2020
  4. This deviceK234147 ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR…Microline Surgical, Inc. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932648Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc.1993—
−2K962119RE-New Laparoscopic InstrumentsMicroline Pentax, Inc.19962
−1K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR…Microline Surgical, Inc.2020—
0 (this device)K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece…Microline Surgical, Inc.2024—
FIG. 1 — Lineage of K234147, 1993–2024Source: 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece…
Summary page 5
…er 878.4400 Product Code GElI M Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201884 ReNew XR Handpiece GEl Device Description Summary 21 CFR 807.92(a)(4) The ReNew XR Handpiece with Reference Markings is a reusab…
Microline Surgical, Inc.2020—

Also cleared against K201884: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • 1 other device also cites its predicate K201884.

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. 2024, this device’s year, is highlighted.

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—

What is it indicated for?

The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures.

The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K201884

1 other device cites the same predicate.

  • K252535Inno-Switch™ Laparoscopic InstrumentsTaiwan Surgical Corporation · 2026

More from Microline Surgical, Inc.

8 FDA decisions under this applicant name. See the company

  • K213127ReNew Disposable Scissor TipsMicroline Surgical, Inc. · 20221 recall
  • K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted…Microline Surgical, Inc. · 2020
  • K160706ReNew V Handpiece Laparoscopic InstrumentsMicroline Surgical, Inc. · 2016
  • K152745ReNew Sterilization Trays (Catalog #3708 and #3709)Microline Surgical, Inc. · 2016
  • K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)Microline Surgical, Inc. · 2016

Recent decisions in GEI

The GEI category page

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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K234147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K234147: ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234147

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026