510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K952732Substantially Equivalent

Medical Grade Silicone Block

Bioplexus Corp., Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952732 is the FDA 510(k) clearance record for MEDICAL GRADE SILICONE BLOCK, a class II device, cleared for Bioplexus Corp. on under FDA product code MIB (Elastomer, Silicone Block). FDA records list 3 510(k) clearances for Bioplexus Corp., from to . As of , FDA records show no recalls naming K952732.

Clearance record

Decision date
Received
(77 days to decision)
Product code
MIB Elastomer, Silicone Block
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bioplexus Corp. 3753 Howard Hughes Pkwy.,, Las Vegas NV
510(k) summary
Summary
Third party review
No

Clearances, product code MIB

Trailing 12 months

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

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