510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831385Substantially Equivalent

Lithotomy Chair #415

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

K831385 is the FDA 510(k) clearance record for LITHOTOMY CHAIR #415, a class I device, cleared for Midmark Corp. on under FDA product code GBB (Chair, Surgical, Ac-Powered). FDA records list 39 510(k) clearances for Midmark Corp., from to . As of , FDA records show no recalls naming K831385.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GBB Chair, Surgical, Ac-Powered
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Midmark Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GBB

Trailing 12 months

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

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