510(k) Report

510(k) · Cleared

Cleared

Spetzler TI 100 Aneurysm Clip

K955064510(k) TraditionalCleared Oct 17, 1996346-day reviewClass II21 CFR 882.5200

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

Elekta Instruments, Inc. · HCH Clip, Aneurysm

Cleared on Oct 17, 1996 as substantially equivalent to K772200 (Aesculap Instruments Corp., 1977) and 5 other predicates after a 346-day review. Its family tree reaches back 1 generation to 1977. 13 later devices descend from it.

Decided
Oct 17, 1996
Review
346 days
Class
Class II
Product code
HCH
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K772200 (1977). 6 ancestors in all. 13 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1992: 2 other ancestors1988: 1 other ancestor1979: 1 other ancestor1999: 2 descendants cleared2000: 2 descendants cleared1998: 1 descendant cleared1997: 1 descendant cleared2001: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2003: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant clearedK772200 · Yasargil Aneurysm Clips · Aesculap Instruments Corp. · 197719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 6 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K772200 · Yasargil Aneurysm Clips · Aesculap Instruments Corp. · 19770+5
  1. Root · 1 generation backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
  2. This deviceK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
  3. Descendant · cites it directly · 8 of its ownK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
  4. Descendant · cites it directly · 6 of its ownK984109 Aesculap Axial Clip ApplierAesculap, Inc. · 1999
  5. Descendant · cites it directly · 6 of its ownK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
  6. Descendant · 2 generations on · 4 of its ownK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
  7. Descendant · 2 generations on · 3 of its ownK173271 Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 22000: 22001: 12003: 12014: 12017: 12018: 12021: 12022: 1
1997high 2 (1999) · low 0 (2002)2026

Most influential descendants

Showing 5 of 13 · See all
  • K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998 · cites it directly8descendants
  • K984109Aesculap Axial Clip ApplierAesculap, Inc. · 1999 · cites it directly6descendants
  • K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997 · cites it directly6descendants
  • K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014 · 2 generations on4descendants
  • K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K772200Yasargil Aneurysm ClipsAesculap Instruments Corp.1977—
0 (this device)K955064Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc.1996—
+1K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc.1998—
+1K984109Aesculap Axial Clip ApplierAesculap, Inc.1999—
+1K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc.1997—
+2K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc.2014—
+2K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198810
199220
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200020
200110
200310
201410
201710
201810
202110
202210
FIG. 1 — Lineage of K955064, 1977–2022Source: 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), 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 HCH? 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 HCH device

  1. #1 K211183 Sugita AVM Microclipsscore 3.2 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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
*K772200Yasargil Aneurysm Clips
Summary page 1
…E DEVICES The Spetzler Ti 100 Aneurysm Clip is substantially equivalent to the Yasargil Aneurysm Clips as manufactured by Aesculap AG, Tutlingen, Germany (as cleared in K772200, K913765, and K922272), the Sugita Aneurysm Clips as manufactured by Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and…
Aesculap Instruments Corp.1977—
*K913765Yasargil Aneurysm Clips, Modification
Summary page 1
…The Spetzler Ti 100 Aneurysm Clip is substantially equivalent to the Yasargil Aneurysm Clips as manufactured by Aesculap AG, Tutlingen, Germany (as cleared in K772200, K913765, and K922272), the Sugita Aneurysm Clips as manufactured by Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and K881911),…
Aesculap, Inc.1992—
*K922272Yasargil Aneurysm Clips
Summary page 1
…r Ti 100 Aneurysm Clip is substantially equivalent to the Yasargil Aneurysm Clips as manufactured by Aesculap AG, Tutlingen, Germany (as cleared in K772200, K913765, and K922272), the Sugita Aneurysm Clips as manufactured by Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and K881911), and the Sund…
Aesculap, Inc.1992—
*K791978Sugita Aneurysm Clips, Appliers & Case
Summary page 1
…sculap AG, Tutlingen, Germany (as cleared in K772200, K913765, and K922272), the Sugita Aneurysm Clips as manufactured by Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and K881911), and the Sundt Slim Line Clip as manufactured by Codman and Shurtleff, Randolph, MA (as cleared in K912456). DEVICE…
Codman & Shurtleff, Inc.1979—
*K881911New Sizes Sugita Clips
Summary page 1
…utlingen, Germany (as cleared in K772200, K913765, and K922272), the Sugita Aneurysm Clips as manufactured by Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and K881911), and the Sundt Slim Line Clip as manufactured by Codman and Shurtleff, Randolph, MA (as cleared in K912456). DEVICE DESCRIPTION…
Downs Surgical, Ltd.1988—
*K912456Sundt Slim-Line Graft Clips
Summary page 1
…y Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and K881911), and the Sundt Slim Line Clip as manufactured by Codman and Shurtleff, Randolph, MA (as cleared in K912456). DEVICE DESCRIPTION Spetzler Ti 100 Aneurysm Clips are manufactured from titanium--Certified ASTM F67-89, "Unalloyed Titanium…
Codman & Shurtleff, Inc.1995—

Also cleared against K772200: 1 other device →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc.19988
K984109Aesculap Axial Clip ApplierAesculap, Inc.19996
K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc.19976
K013136Aneurysm ClipsGistlstrasse20010
K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc.20000
K990202Sugita Titanium Aneurysm ClipMizuho America, Inc.19990

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K983758 (Aesculap, Inc., 1998) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K772200.

How does its category compare?

All HCH devices

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

FDA decisions per year · HCH

1in 2022

2007: 12008: 12009: 22014: 12019: 12022: 1
2007high 2 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCH

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

Recalls per year · HCH

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · HCH

2in 2025

2010: 42012: 42013: 32014: 132015: 92016: 52017: 12018: 192019: 92020: 92021: 132022: 12023: 102024: 92025: 2
2007high 19 (2018) · low 0 (2007)2025

MAUDE reports naming product code HCH, 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
20071—00
20081—00
20092—00
20100—04
20110—00
20120—04
20130—23
20141—013
20150—09
20160—05
20170—01
20180—019
20191—09
20200—09
20210—013
20221—01
20230—010
20240—09
20250—02
20260—0—

What is it indicated for?

The Spetzler Ti 100 Aneurysm Clips are intended for:

Temporary occlusion of intracranial blood vessels/aneurysms

Permanent placement in the brain for occlusion of intracranial aneurysms

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 K772200

1 other device cites the same predicate.

  • K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017

More from Elekta Instruments, Inc.

8 FDA decisions under this applicant name. See the company

  • K983678Elekta Oncology Systems Precise Treatment TableElekta Instruments, Inc. · 19994 recalls
  • K941823Leksell Neuro Generator and AccessoriesElekta Instruments, Inc. · 1996
  • K946165CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemElekta Instruments, Inc. · 1995
  • K943468Leksell SurgiplanElekta Instruments, Inc. · 19951 recall
  • K932261ES-100 AccessoriesElekta Instruments, Inc. · 1994

Recent decisions in HCH

The HCH category page

  • K211183Sugita AVM MicroclipsMizuho America, Inc. · 2022
  • K180757D-Clip; D-Clip ApplierPeter Lazic GmbH · 20193 recalls
  • K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
  • K091921Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm ClipCodman & Shurtleff, Inc. · 2009
  • K081640Gimmi Aneurysm Clips and Applying ForcepsGimmi GmbH · 2009

https://510kreport.com/device/K955064 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955064: Spetzler TI 100 Aneurysm Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955064

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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