510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991023Substantially Equivalent

Steritite Perforated Bottom Rigid Reusable Sterilization Container System with Scf02 - Polypropylene Non-Woven Disposabl

Case Medical, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991023 is the FDA 510(k) clearance record for STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL, a class II device, cleared for Case Medical, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 16 510(k) clearances for Case Medical, Inc., from to . As of , FDA records show no recalls naming K991023.

Clearance record

Decision date
Received
(304 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Case Medical, Inc. 1900 K St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260