510(k) Report

510(k) · Cleared

Cleared

1.9 French Lithotripter Electrode, Modification

K913955510(k) TraditionalCleared Nov 29, 199185-day reviewClass II21 CFR 876.4480

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

Northgate Technologies, Inc. · FFK Lithotriptor, Electro-Hydraulic

Cleared on Nov 29, 1991 after an 85-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
Nov 29, 1991
Review
85 days
Class
Class II
Product code
FFK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2023: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK913955 1.9 French Lithotripter Electrode, ModificationNorthgate Technologies, Inc. · 1991
  2. Descendant · cites it directly · 2 of its ownK230488 EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023
  3. Descendant · 2 generations on · 0 of its ownK243032 EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
  4. Descendant · 2 generations on · 0 of its ownK242888 Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025

Most influential descendants

Showing 3 of 3 · See all
  • K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023 · cites it directly2descendants
  • K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · 2 generations on0descendants
  • K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9139551.9 French Lithotripter Electrode, ModificationNorthgate Technologies, Inc.1991—
+1K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH2023—
+2K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025—
+2K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202520
FIG. 1 — Lineage of K913955, 1991–2025Source: 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 FFK? 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 FFK device

  1. #1 K230488 EL27-Compact; Sterile EHL-Probesscore 12.2 · 2 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH20232

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, K230488 (Walz Elektronik GmbH, 2023) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FFK devices

FFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFK

2in 2025

2007: 22010: 22012: 22013: 32016: 22019: 12021: 12023: 12025: 2
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFK

110in 2013

2013: 110 days median
2007high 110 (2013)2026

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

Recalls per year · FFK

1in 2021

2007: 12009: 12017: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FFK

6in 2025

2007: 62008: 122009: 352010: 162011: 62012: 22013: 102014: 92015: 72016: 72017: 92018: 182019: 102020: 392021: 222022: 132023: 102024: 82025: 6
2007high 39 (2020) · low 2 (2012)2025

MAUDE reports naming product code FFK, 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
20072—16
20080—012
20090—135
20102—016
20110—06
20122—02
20133110010
20140—09
20150—07
20162—07
20170—19
20180—018
20191—010
20200—039
20211—122
20220—013
20231—010
20240—08
20252—06
20260—0—

More from Northgate Technologies, Inc.

55 FDA decisions under this applicant name. See the company

  • K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. · 2021
  • K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc. · 2021
  • K130368Autolith Touch; Uro TouchNorthgate Technologies, Inc. · 20134 recalls
  • K120151Nebulae INorthgate Technologies, Inc. · 20122 recalls
  • K041560Flo-AssistantNorthgate Technologies, Inc. · 2004

Recent decisions in FFK

The FFK category page

  • K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
  • K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
  • K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023
  • K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. · 2021
  • K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2019

https://510kreport.com/device/K913955 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913955: 1.9 French Lithotripter Electrode, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913955

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