510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934494Substantially Equivalent

Surgitel

General Scientific Corp., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934494 is the FDA 510(k) clearance record for SURGITEL, a class I device, cleared for General Scientific Corp. on under FDA product code HOH (Spectacle, Operating (Loupe), Ophthalmic). FDA records list one 510(k) clearance for General Scientific Corp. As of , FDA records show no recalls naming K934494.

Clearance record

Decision date
Received
(132 days to decision)
Product code
HOH Spectacle, Operating (Loupe), Ophthalmic
Regulation
21 CFR 886.4770
Device class
Class I
Review panel
Ophthalmic
Applicant
General Scientific Corp. 77 Enterprise Dr., Ann Arbor MI
510(k) summary
Statement
Third party review
No

Clearances, product code HOH

Trailing 12 months

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

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