510(k) Report

510(k) · Decided

Decided

Skin Staple Removal Trays

K943046510(k) TraditionalDecided Jul 29, 199432-day reviewClass I21 CFR 878.4800

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

Sterile Concepts, Inc. · MCZ Suture Removal Kit

Cleared on Jul 29, 1994 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 29, 1994
Review
32 days
Class
Class I
Product code
MCZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K943046Source: 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 MCZ? 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 MCZ devices

MCZ Suture Removal Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCZ

FDA has decided no MCZ device since 2007.

Median 510(k) review, days · MCZ

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

Recalls per year · MCZ

1in 2014

2009: 22011: 22014: 1, 1 Class I
2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MCZ

5in 2024

2007: 12015: 12016: 12017: 22018: 32019: 22020: 32021: 42022: 12023: 22024: 5
2007high 5 (2024) · low 0 (2008)2025

MAUDE reports naming product code MCZ, 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—01
20080—00
20090—20
20100—00
20110—20
20120—00
20130—00
20140—1 (1)0
20150—01
20160—01
20170—02
20180—03
20190—02
20200—03
20210—04
20220—01
20230—02
20240—05
20250—00
20260—0—

More from Sterile Concepts, Inc.

10 FDA decisions under this applicant name. See the company

  • K951231Orthopedic PacksSterile Concepts, Inc. · 1995
  • K951081OB/Gyn PacksSterile Concepts, Inc. · 1995
  • K952539Radiology PacksSterile Concepts, Inc. · 1995
  • K951478General and Plastic Surgery PacksSterile Concepts, Inc. · 1995
  • K944139Dental Hygiene TraySterile Concepts, Inc. · 1994

Recent decisions in MCZ

The MCZ category page

  • K050656Amsino Suture Removal KitAmsino International, Inc. · 2005
  • K964827Prod. NO. 01-132 - Suture Removal KitContinental Medical Laboratories, Inc. · 1997
  • K963714Grand Medical Suture Removal KitGrand Medical Products · 1996
  • K941465Suture Removal KitClinical Resources, Inc. · 1994
  • K931597Carapace Incision and Drainage TraysCarapace, Inc. · 1993

https://510kreport.com/device/K943046 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943046: Skin Staple Removal Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943046

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