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
K033991Substantially Equivalent

Modification to Laparoshield Conditioned Insufflation Set

Pall Medical, Washington DC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033991 is the FDA 510(k) clearance record for MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET, a class II device, cleared for Pall Medical on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list 6 510(k) clearances for Pall Medical, from to . As of , FDA records show no recalls naming K033991.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pall Medical 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260