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
K822427Substantially Equivalent

Self-Contained Mobile Ophthal. Oper. .

Surgi-Quip Inc.U, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822427 is the FDA 510(k) clearance record for SELF-CONTAINED MOBILE OPHTHAL. OPER. ., a class I device, cleared for Surgi-Quip Inc.U on under FDA product code FSE (Table, Operating-Room, Manual). FDA records list 8 510(k) clearances for Surgi-Quip Inc.U, from to . As of , FDA records show no recalls naming K822427.

Clearance record

Decision date
Received
(33 days to decision)
Product code
FSE Table, Operating-Room, Manual
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Surgi-Quip Inc.U 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FSE

Trailing 12 months

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

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