510(k) Report

510(k) · Cleared

Cleared

Scoville-Lewis Aneurysm Clips

K791764510(k) TraditionalCleared Oct 1, 197934-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

Codman & Shurtleff, Inc. · HCH Clip, Aneurysm

Cleared on Oct 1, 1979 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Oct 1, 1979
Review
34 days
Class
Class II
Product code
HCH
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2000: 1 descendant cleared19801990200020102020
  1. This deviceK791764 Scoville-Lewis Aneurysm ClipsCodman & Shurtleff, Inc. · 1979
  2. Descendant · cites it directly · 1 of its ownK982379 Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
  3. Descendant · 2 generations on · 0 of its ownK994191 Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754…Nmt Medical, Inc. · 2000

Most influential descendants

Showing 2 of 2 · See all
  • K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998 · cites it directly1descendant
  • K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc. · 2000 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K791764Scoville-Lewis Aneurysm ClipsCodman & Shurtleff, Inc.1979—
+1K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc.1998—
+2K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
FIG. 1 — Lineage of K791764, 1979–2000Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc.19981

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, K982379 (Johnson & Johnson Professionals, Inc., 1998) has gone furthest, with 1 descendant of its own.

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—

More from Codman & Shurtleff, Inc.

152 FDA decisions under this applicant name. See the company

  • K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
  • K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
  • K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull…Codman & Shurtleff, Inc. · 20171 recall
  • K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagCodman & Shurtleff, Inc. · 2017
  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 20171 recall

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/K791764 · printed Nov 5, 2026

Cite this page

510(k) Report. “K791764: Scoville-Lewis Aneurysm Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K791764

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026