510(k) Report

510(k) · Cleared

Cleared

Hysteroscopic Myoma Screw

K915412510(k) TraditionalCleared May 18, 1992168-day reviewClass II21 CFR 884.4530

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

Cook Urological, Inc. · HHO Screw, Fibroid, Gynecological

Cleared on May 18, 1992 after a 168-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 18, 1992
Review
168 days
Class
Class II
Product code
HHO
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K915412Source: FDA 510(k) database · 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

How does its category compare?

All HHO devices

HHO Screw, Fibroid, Gynecological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHO

FDA has decided no HHO device since 2007.

Median 510(k) review, days · HHO

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

Recalls per year · HHO

No recall names HHO since 2007.

Adverse event reports per year · HHO

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code HHO, 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—00
20080—00
20090—00
20100—01
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in HHO

The HHO category page

  • K915388Laparocopic Myoma ScrewCook Urological, Inc. · 1992

https://510kreport.com/device/K915412 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915412: Hysteroscopic Myoma Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915412

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