510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931847Substantially Equivalent

Bio-Prep Cement Restrictor

Biomedical Devices, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931847 is the FDA 510(k) clearance record for BIO-PREP CEMENT RESTRICTOR, a class II device, cleared for Biomedical Devices, Inc. on under FDA product code LZN (Cement Obturator). FDA records list 7 510(k) clearances for Biomedical Devices, Inc., from to . As of , FDA records show 7 recalls naming K931847.

Clearance record

Decision date
Received
(441 days to decision)
Product code
LZN Cement Obturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biomedical Devices, Inc. 1752 A Langley Ave., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code LZN

Trailing 12 months

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

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