510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K974062Substantially Equivalent

Medsci 3% Glutaraldehyde

Medsci, Inc., Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974062 is the FDA 510(k) clearance record for MEDSCI 3% GLUTARALDEHYDE, a class II device, cleared for Medsci, Inc. on under FDA product code MED (Sterilant, Medical Devices). FDA records list one 510(k) clearance for Medsci, Inc. As of , FDA records show no recalls naming K974062.

Clearance record

Decision date
Received
(310 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
Medsci, Inc. P.O. Box 5248, Greensboro NC
510(k) summary
Summary
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED 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 MED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260