510(k) Report

510(k) · Cleared

Cleared

Suture Applier Device

K905722510(k) TraditionalCleared Mar 14, 199184-day reviewClass II21 CFR 876.1500

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

Laparomed Corp. · MFJ Device, Endoscopic Suturing

Cleared on Mar 14, 1991 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 14, 1991
Review
84 days
Class
Class II
Product code
MFJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K905722Source: 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 MFJ? 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 MFJ devices

MFJ Device, Endoscopic Suturing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MFJ

FDA has decided no MFJ device since 2007.

Median 510(k) review, days · MFJ

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

Recalls per year · MFJ

No recall names MFJ since 2007.

Adverse event reports per year · MFJ

1in 2023

2007: 512008: 1122009: 1152010: 402011: 222012: 112013: 42014: 52015: 112016: 62017: 42018: 12023: 1
2007high 115 (2009) · low 0 (2019)2025

MAUDE reports naming product code MFJ, 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—051
20080—0112
20090—0115
20100—040
20110—022
20120—011
20130—04
20140—05
20150—011
20160—06
20170—04
20180—01
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Laparomed Corp.

10 FDA decisions under this applicant name. See the company

  • K934527Fascia StitcherLaparomed Corp. · 1994
  • K930569Laparomed Laparoscopic Retractor SystemLaparomed Corp. · 1993
  • K921921Catheter CholangiographyLaparomed Corp. · 1992
  • K921053Laparomed Ligating LoopLaparomed Corp. · 1992
  • K921006Laparoscopic Retractor SystemLaparomed Corp. · 1992

https://510kreport.com/device/K905722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905722: Suture Applier Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905722

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