510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933310Substantially Equivalent

Micrins Contrast Background Material

Micrins Surgical, Inc., Lake Forest IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933310 is the FDA 510(k) clearance record for MICRINS CONTRAST BACKGROUND MATERIAL, a class I device, cleared for Micrins Surgical, Inc. on under FDA product code EPT (Microscope, Surgical). FDA records list 6 510(k) clearances for Micrins Surgical, Inc., from to . As of , FDA records show no recalls naming K933310.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EPT Microscope, Surgical
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Micrins Surgical, Inc. 28438 Ballard Dr., Lake Forest IL
510(k) summary
Statement
Third party review
No

Clearances, product code EPT

Trailing 12 months

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

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