510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790877Substantially Equivalent

Biovac: Lfa Laser Fume (Smoke) Evacuatio

Stackhouse Assoc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790877 is the FDA 510(k) clearance record for BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO, a class I device, cleared for Stackhouse Assoc. on under FDA product code JDY (Evacuator, Vapor, Cement Monomer). FDA records list 5 510(k) clearances for Stackhouse Assoc., from to . As of , FDA records show no recalls naming K790877.

Clearance record

Decision date
Received
(16 days to decision)
Product code
JDY Evacuator, Vapor, Cement Monomer
Regulation
21 CFR 888.4220
Device class
Class I
Review panel
Orthopedic
Applicant
Stackhouse Assoc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JDY

Trailing 12 months

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

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