510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K934291Substantially Equivalent

Surgicot Fog Free

Ssa Aquisition Corp., Research Triangle Park NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934291 is the FDA 510(k) clearance record for SURGICOT FOG FREE, a class II device, cleared for Ssa Aquisition Corp. on under FDA product code OCT (Anti Fog Solution And Accessories, Endoscopy). FDA's definition for product code OCT reads: "To prevent, reduce or eliminate condensation (fog) on endoscopic lens". FDA records list one 510(k) clearance for Ssa Aquisition Corp. As of , FDA records show no recalls naming K934291.

Clearance record

Decision date
Received
(179 days to decision)
Product code
OCT Anti Fog Solution And Accessories, Endoscopy
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ssa Aquisition Corp. 1 Patriot Dr., Research Triangle Park NC
510(k) summary
Summary
Third party review
No

Clearances, product code OCT

Trailing 12 months

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

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