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
K954401Substantially Equivalent

Gastrotec

Patrick C. Jacobssen, Fairhope AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954401 is the FDA 510(k) clearance record for GASTROTEC, a class III device, cleared for Patrick C. Jacobssen on under FDA product code ESI (Polymer, Natural-Absorbable Gelatin Material). FDA records list one 510(k) clearance for Patrick C. Jacobssen. As of , FDA records show no recalls naming K954401.

Clearance record

Decision date
Received
(218 days to decision)
Product code
ESI Polymer, Natural-Absorbable Gelatin Material
Device class
Class III
Review panel
Unknown
Applicant
Patrick C. Jacobssen 19730 Huntrs Loop, Fairhope AL
510(k) summary
Statement
Third party review
No

Clearances, product code ESI

Trailing 12 months

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

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