510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921006Substantially Equivalent

Laparoscopic Retractor System

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

K921006 is the FDA 510(k) clearance record for LAPAROSCOPIC RETRACTOR SYSTEM, a class II device, cleared for Laparomed Corp. on under FDA product code GCS (Endoscope, Battery-Powered And Accessories). FDA records list 10 510(k) clearances for Laparomed Corp., from to . As of , FDA records show no recalls naming K921006.

Clearance record

Decision date
Received
(147 days to decision)
Product code
GCS Endoscope, Battery-Powered And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laparomed Corp. 9272 Jeronimo Rd., Unit 109, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code GCS

Trailing 12 months

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

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