510(k) Report

510(k) · Cleared

Cleared

Ruwa Finishing Strips

K790598510(k) TraditionalCleared May 21, 197956-day reviewClass I21 CFR 872.6010

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

Howmedica Corp. · EHM Strip, Polishing Agent

Cleared on May 21, 1979 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 21, 1979
Review
56 days
Class
Class I
Product code
EHM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790598Source: 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.

Planning a device in EHM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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?

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 EHM devices

EHM Strip, Polishing Agent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EHM

FDA has decided no EHM device since 2007.

Median 510(k) review, days · EHM

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

Recalls per year · EHM

No recall names EHM since 2007.

Adverse event reports per year · EHM

No MAUDE report names EHM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
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 Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in EHM

The EHM category page

  • K821364Proflex Flexible ScalerTeledyne Densco · 1982

https://510kreport.com/device/K790598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790598: Ruwa Finishing Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790598

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