510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905722Substantially Equivalent

Suture Applier Device

Laparomed Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905722 is the FDA 510(k) clearance record for SUTURE APPLIER DEVICE, a class II device, cleared for Laparomed Corp. on under FDA product code MFJ (Device, Endoscopic Suturing). FDA records list 10 510(k) clearances for Laparomed Corp., from to . As of , FDA records show no recalls naming K905722.

Clearance record

Decision date
Received
(84 days to decision)
Product code
MFJ Device, Endoscopic Suturing
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laparomed Corp. 9272 Jeronimo Rd., Unit 109, Irvine CA
Third party review
No

Clearances, product code MFJ

Trailing 12 months

FDA records hold no clearances under product code MFJ in the trailing twelve months.

FDA records show no clearances under product code MFJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MFJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260