510(k) Report

510(k) · Cleared

Cleared

Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T

K994191510(k) TraditionalCleared Feb 8, 200057-day reviewClass II21 CFR 882.4175

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

Nmt Medical, Inc. · HCI Applier, Aneurysm Clip

Cleared on Feb 8, 2000 as substantially equivalent to K955064 (Elekta Instruments, Inc., 1996) and 3 other predicates after a 57-day review. Its family tree reaches back 3 generations to 1977.

Decided
Feb 8, 2000
Review
57 days
Class
Class II
Product code
HCI
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K772200 (1977). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1995: 2 other ancestors1992: 2 other ancestors1988: 1 other ancestor1983: 1 other ancestor1979: 2 other ancestorsK772200 · Yasargil Aneurysm Clips · Aesculap Instruments Corp. · 1977K955064 · Spetzler TI 100 Aneurysm Clip · Elekta Instruments, Inc. · 1996K984109 · Aesculap Axial Clip Applier · Aesculap, Inc. · 1999197519801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors K984109 · Aesculap Axial Clip Applier · Aesculap, Inc. · 1999K955064 · Spetzler TI 100 Aneurysm Clip · Elekta Instruments, Inc. · 1996K772200 · Yasargil Aneurysm Clips · Aesculap Instruments Corp. · 19770
  1. Root · 3 generations backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
  2. 2 generations backK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
  3. 1 generation backK984109 Aesculap Axial Clip ApplierAesculap, Inc. · 1999
  4. This deviceK994191 Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754…Nmt Medical, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K772200Yasargil Aneurysm ClipsAesculap Instruments Corp.1977—
−2K955064Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc.1996—
−1K984109Aesculap Axial Clip ApplierAesculap, Inc.1999—
0 (this device)K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197920
198310
198810
199220
199520
199810
FIG. 1 — Lineage of K994191, 1977–2000Source: 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 HCI? 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 HCI device

  1. #1 K211572 Aesculap Slim Clip Applierscore 7.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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
*K955064Spetzler TI 100 Aneurysm Clip
Summary page 3
…rial composition, function and intended use as the following clip appliers currently in commercial distribution and cleared by the FDA: Elekta Clip Appliers (Elekta) (K955064) Aesculap Axial Clip Appliers (Aesculap) (K984109) Yasargil, Caspar, Vario Clip Appliers (Aesculap) (K940970) Sundt Slim-Line…
Elekta Instruments, Inc.1996—
*K984109Aesculap Axial Clip Applier
Summary page 3
…following clip appliers currently in commercial distribution and cleared by the FDA: Elekta Clip Appliers (Elekta) (K955064) Aesculap Axial Clip Appliers (Aesculap) (K984109) Yasargil, Caspar, Vario Clip Appliers (Aesculap) (K940970) Sundt Slim-Line Aneurysm Clip Applier (J & J Prof, Inc.) (K982379)…
Aesculap, Inc.1999—
*K940970Yasargil, Caspar, Vario Clip Appliers
Summary page 3
…and cleared by the FDA: Elekta Clip Appliers (Elekta) (K955064) Aesculap Axial Clip Appliers (Aesculap) (K984109) Yasargil, Caspar, Vario Clip Appliers (Aesculap) (K940970) Sundt Slim-Line Aneurysm Clip Applier (J & J Prof, Inc.) (K982379) 66042 avice,, l& sfl' g DEPARTMENT OF HEAL…
Aesculap, Inc.19952
*K982379Sundt Slim-Line Aneurysm Clip Applier
Summary page 3
…Aesculap Axial Clip Appliers (Aesculap) (K984109) Yasargil, Caspar, Vario Clip Appliers (Aesculap) (K940970) Sundt Slim-Line Aneurysm Clip Applier (J & J Prof, Inc.) (K982379) 66042 avice,, l& sfl' g DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ® M Food and Drug Adminis…
Johnson & Johnson Professionals, Inc.1998—

Also cleared against K955064: 5 other devices →

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 23 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K955064.

How does its category compare?

All HCI devices

HCI Applier, Aneurysm Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCI

1in 2022

2017: 12018: 12021: 12022: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCI

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

Recalls per year · HCI

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · HCI

1in 2025

2013: 272014: 12015: 12017: 22019: 62020: 22021: 62022: 12023: 22024: 32025: 1
2007high 27 (2013) · low 0 (2007)2025

MAUDE reports naming product code HCI, 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
20070—20
20080—00
20090—00
20100—00
20110—00
20120—00
20130—027
20140—01
20150—01
20160—00
20171—02
20181—00
20190—06
20200—02
20211—06
20221—01
20230—02
20240—03
20250—01
20260—0—

What is it indicated for?

Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.

The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.

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 K955064

5 other devices cite the same predicate.

  • K013136Aneurysm ClipsGistlstrasse · 2001
  • K990202Sugita Titanium Aneurysm ClipMizuho America, Inc. · 19992 recalls
  • K984109Aesculap Axial Clip ApplierAesculap, Inc. · 1999
  • K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
  • K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997

More from Nmt Medical, Inc.

17 FDA decisions under this applicant name. See the company

  • P000049/S016Starflex Septal Occlusion SystemNmt Medical, Inc. · 2009
  • P000049/S019Cardioseal Septal Occlusion with Qwik LoadNmt Medical, Inc. · 2008
  • P000049/S015Cardioseal Septal Occlusion System with Qwik LoadNmt Medical, Inc. · 2004
  • P000049/S014Cardioseal Septal Occlusion System with QwikloadNmt Medical, Inc. · 2004
  • P000049/S013Cardioseal Septal Occlusion SystemNmt Medical, Inc. · 2004

Recent decisions in HCI

The HCI category page

  • K221524Sugita AVM Microclip ApplierMizuho America, Inc. · 2022
  • K211572Aesculap Slim Clip ApplierAesculap, Inc. · 2021
  • K180914Aesculap Slim Clip ApplierAesculap, Inc. · 2018
  • K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017
  • K010910Medicon Yasargil Clip Applying ForcepsMedicon EG · 2001

https://510kreport.com/device/K994191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994191: Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994191

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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