510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K973803Substantially Equivalent

Flexview CO2 Blower with Mist

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973803 is the FDA 510(k) clearance record for FLEXVIEW CO2 BLOWER WITH MIST, a class II device, cleared for Ethicon Endo-Surgery, Inc. on under FDA product code FQH (Lavage, Jet). FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, Inc., from to . As of , FDA records show no recalls naming K973803.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FQH Lavage, Jet
Regulation
21 CFR 880.5475
Device class
Class II
Review panel
General Hospital
Applicant
Ethicon Endo-Surgery, Inc. 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary
Third party review
No

Clearances, product code FQH

Trailing 12 months
2 clearances under product code FQH in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FQH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260