510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850883Substantially Equivalent

Scleral Sponge II, Olk Design, E5395-10 & E5395-11

Storz Instrument Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850883 is the FDA 510(k) clearance record for SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11, a class II device, cleared for Storz Instrument Co. on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list 101 510(k) clearances for Storz Instrument Co., from to . As of , FDA records show no recalls naming K850883.

Clearance record

Decision date
Received
(16 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
Storz Instrument Co. 3365 Tree Ct. Industrial Blvd., St. Louis MO
Third party review
No

Clearances, product code HOZ

Trailing 12 months

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

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