510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894220Substantially Equivalent

Houts Hysterectomy Drain

Freudenberg Medical, LLC, Santa Barbera CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894220 is the FDA 510(k) clearance record for HOUTS HYSTERECTOMY DRAIN, a class I device, cleared for Helix Medical, Inc. on under FDA product code GBW (Catheter, Peritoneal). FDA records list 21 510(k) clearances for Freudenberg Medical, LLC, from to . As of , FDA records show no recalls naming K894220.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GBW Catheter, Peritoneal
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Helix Medical, Inc. 210 Santa Barbera St., Santa Barbera CA
Third party review
No

Clearances, product code GBW

Trailing 12 months

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

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