510(k) Report

510(k) · Cleared

Cleared

PMS 750 Fingerswitch

K991669510(k) TraditionalCleared Aug 12, 199990-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

Wallach Surgical Devices, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 12, 1999 as substantially equivalent to K983761 (Aaron Medical Industries, 1998) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1991.

Decided
Aug 12, 1999
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K914400 (1991). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1996: 1 other ancestorK914400 · Models E2502B/E2525 Reusable Handswitching Pencils · Valleylab, Inc. · 1991K983761 · Aaron Electrosurgical Handcontrol Pencil, Model ESP5 · Aaron Medical Industries · 1998199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K983761 · Aaron Electrosurgical Handcontrol Pencil, Model ESP5 · Aaron Medical Industries · 1998K914400 · Models E2502B/E2525 Reusable Handswitching Pencils · Valleylab, Inc. · 19910
  1. Root · 2 generations backK914400 Models E2502B/E2525 Reusable Handswitching PencilsValleylab, Inc. · 1991
  2. 1 generation backK983761 Aaron Electrosurgical Handcontrol Pencil, Model ESP5Aaron Medical Industries · 1998
  3. This deviceK991669 PMS 750 FingerswitchWallach Surgical Devices, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K914400Models E2502B/E2525 Reusable Handswitching PencilsValleylab, Inc.1991—
−1K983761Aaron Electrosurgical Handcontrol Pencil, Model ESP5Aaron Medical Industries1998—
0 (this device)K991669PMS 750 FingerswitchWallach Surgical Devices, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199610
199710
FIG. 1 — Lineage of K991669, 1991–1999Source: 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
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What was it cleared against? (4)

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
*K983761Aaron Electrosurgical Handcontrol Pencil, Model ESP5
Summary page 1
…Code 79 GEL Regulation Number 878.4400, 21 CFR. Predicate Devices to which we are claiming substantial equivalence: Aaron Electrosurgical Handcontrol Pencil, Reusable, K983761, 12/30/98. Medtrex’s Encore™ Electrosurgical Pencil (35001-), Reusable, K970039, 02/26/97. E & M Engineering’s Reusable Hand Con…
Aaron Medical Industries1998—
*K970039Encore Electrosurgical Handcontrol Pencil (35001-001)
Summary page 1
…e claiming substantial equivalence: Aaron Electrosurgical Handcontrol Pencil, Reusable, K983761, 12/30/98. Medtrex’s Encore™ Electrosurgical Pencil (35001-), Reusable, K970039, 02/26/97. E & M Engineering’s Reusable Hand Controlled ESP, Reusable, K936075, 06/06/94. Conmed’s Tech-Switch Electrosurgical Pe…
Medtrex, Inc.1997—
*K936075Reusable, Hand Controlled Esp
Summary page 1
…Reusable, K983761, 12/30/98. Medtrex’s Encore™ Electrosurgical Pencil (35001-), Reusable, K970039, 02/26/97. E & M Engineering’s Reusable Hand Controlled ESP, Reusable, K936075, 06/06/94. Conmed’s Tech-Switch Electrosurgical Pencil, Reusable, K932518, 10/12/93. AW N Product Description: The PMS750 Fing…
E & M Engineering, Inc.1994—
*K932518Tech-Switch Electrosurgical Pencil, Reusable
Summary page 1
…001-), Reusable, K970039, 02/26/97. E & M Engineering’s Reusable Hand Controlled ESP, Reusable, K936075, 06/06/94. Conmed’s Tech-Switch Electrosurgical Pencil, Reusable, K932518, 10/12/93. AW N Product Description: The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcon…
Conmedcorp1993—

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 8 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
  • None of the 6 ancestors has a recall.

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—

What is it indicated for?

The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

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

More from Wallach Surgical Devices, Inc.

27 FDA decisions under this applicant name. See the company

  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
  • K020711Wallach Loop ElectrodeWallach Surgical Devices, Inc. · 20021 recall
  • K000768Wallach Quantum 500 Electrosurgical GeneratorWallach Surgical Devices, Inc. · 2000
  • K992736Wallach's Ultimate Reusable, Plastic Vaginal SpeculumWallach Surgical Devices, Inc. · 1999
  • K983840Wallach Quantum 500 Electrosurgical Generator (Proposed)Wallach Surgical Devices, Inc. · 1999

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The GEI category page

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https://510kreport.com/device/K991669 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991669: PMS 750 Fingerswitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991669

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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