510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921053Substantially Equivalent

Laparomed Ligating Loop

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

K921053 is the FDA 510(k) clearance record for LAPAROMED LIGATING LOOP, a class I device, cleared for Laparomed Corp. on under FDA product code KCJ (Applicator, Ent). FDA records list 10 510(k) clearances for Laparomed Corp., from to . As of , FDA records show no recalls naming K921053.

Clearance record

Decision date
Received
(154 days to decision)
Product code
KCJ Applicator, Ent
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Laparomed Corp. 9272 Jeronimo Rd., Unit 109, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code KCJ

Trailing 12 months

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

FDA records show no clearances under product code KCJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KCJ, 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