510(k) Report

510(k) · Cleared

Cleared

Yasargil Aneurysm Clips and Clip Appliers

K131500510(k) TraditionalCleared Jan 24, 2014245-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

Aesculap, Inc. · HCH Clip, Aneurysm

Cleared on Jan 24, 2014 as substantially equivalent to K043041 (Aesculap, Inc., 2004) and 11 other predicates after a 245-day review. Its family tree reaches back 3 generations to 1977. 4 later devices descend from it.

Decided
Jan 24, 2014
Review
245 days
Class
Class II
Product code
HCH
Recalls
None
Predicates
12

Its longest line of descent runs back 3 generations to K772200 (1977). 18 ancestors in all, the oldest K760771 (1976). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1995: 2 other ancestors1992: 2 other ancestors1984: 2 other ancestors1983: 1 other ancestor1976: 1 other ancestor1988: 1 other ancestor1979: 1 other ancestor2018: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant clearedK772200 · Yasargil Aneurysm Clips · Aesculap Instruments Corp. · 1977K955064 · Spetzler TI 100 Aneurysm Clip · Elekta Instruments, Inc. · 1996K970050 · Yasargil Titanium Aneurysm Clips (Ftxxxt) · Aesculap, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 1 other ancestor3 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K970050 · Yasargil Titanium Aneurysm Clips (Ftxxxt) · Aesculap, Inc. · 1997K955064 · 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 backK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
  4. This deviceK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
  5. Descendant · cites it directly · 3 of its ownK173271 Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017
  6. Descendant · cites it directly · 2 of its ownK180914 Aesculap Slim Clip ApplierAesculap, Inc. · 2018
  7. Descendant · 2 generations on · 1 of its ownK211572 Aesculap Slim Clip ApplierAesculap, Inc. · 2021
  8. Descendant · 3 generations on · 0 of its ownK221524 Sugita AVM Microclip ApplierMizuho America, Inc. · 2022

Most influential descendants

Showing 4 of 4 · See all
  • K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017 · cites it directly3descendants
  • K180914Aesculap Slim Clip ApplierAesculap, Inc. · 2018 · cites it directly2descendants
  • K211572Aesculap Slim Clip ApplierAesculap, Inc. · 2021 · 2 generations on1descendant
  • K221524Sugita AVM Microclip ApplierMizuho America, Inc. · 2022 · 3 generations on0descendants
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—
−1K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc.1997—
0 (this device)K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc.2014—
+1K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.2017—
+1K180914Aesculap Slim Clip ApplierAesculap, Inc.2018—
+2K211572Aesculap Slim Clip ApplierAesculap, Inc.2021—
+3K221524Sugita AVM Microclip ApplierMizuho America, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197610
197910
198310
198420
198810
199220
199520
199810
199910
200010
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202110
202210
FIG. 1 — Lineage of K131500, 1977–2022Source: 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 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
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What was it cleared against? (12)

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
*K043041Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)
Summary page 1
…E Aesculap, Inc. believes that the Aesculap Yasargil Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Cl…
Aesculap, Inc.2004—
*K003519Yasargil Permanent Aneurysm Clips
Summary page 1
…ap, Inc. believes that the Aesculap Yasargil Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc d…
Aesculap, Inc.2001—
*K002871Modification to Yasargil Aneurysm Clips
Summary page 1
…believes that the Aesculap Yasargil Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed f…
Aesculap, Inc.2000—
*K984109Aesculap Axial Clip Applier
Summary page 1
…that the Aesculap Yasargil Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for tempor…
Aesculap, Inc.1999—
*K983758Yasargil Titanium Aneurysm Clips
Summary page 1
…Aesculap Yasargil Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or pe…
Aesculap, Inc.1998—
*K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)
Summary page 1
…Yasargil Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent o…
Aesculap, Inc.1997—
*K940970Yasargil, Caspar, Vario Clip Appliers
Summary page 1
…Aneurysm Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent occlusion…
Aesculap, Inc.19952
*K922272Yasargil Aneurysm Clips
Summary page 1
…Clips and Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent occlusion of vessel…
Aesculap, Inc.1992—
*K913765Yasargil Aneurysm Clips, Modification
Summary page 1
…Clip Appliers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent occlusion of vessels during…
Aesculap, Inc.1992—
*K833652Yasargil Fenestrated Aneurysm Clip &
Summary page 1
…liers are substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent occlusion of vessels during neurosurg…
Advanced Biosearch Assn.1984—
*K833651Clip Applying Forceps
Summary page 1
…substantiafly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent occlusion of vessels during neurosurgical proc…
Advanced Biosearch Assn.1983—
*K833650Yasargil Standard Aneurysm Clip &
Summary page 1
…ly to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519, K002871, K984109, K983758, K970050, K940970. K922272, K913765, K833652, K833651 and K833650). The Yasargil Aneurvsm Clips arc designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They…
Advanced Biosearch Assn.1984—

Also cleared against K043041: 1 other device →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.20173
K180914Aesculap Slim Clip ApplierAesculap, Inc.20182

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 37 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
  • 1 of the 18 ancestors has a recall of any class.
  • Of its descendants, K173271 (Aesculap, Inc., 2017) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K043041.

How does its category compare?

All HCH devices

HCH Clip, Aneurysm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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 Yasargil Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied with Aesculap clip appliers, which contain titanium alloy or phynox jaws.

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

Cite this page

510(k) Report. “K131500: Yasargil Aneurysm Clips and Clip Appliers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131500

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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