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
K932281Substantially Equivalent

Verres Needle

Surgeon Surgical Instrumentation, Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932281 is the FDA 510(k) clearance record for VERRES NEEDLE, a class II device, cleared for Surgeon Surgical Instrumentation, Inc. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 10 510(k) clearances for Surgeon Surgical Instrumentation, Inc., from to . As of , FDA records show no recalls naming K932281.

Clearance record

Decision date
Received
(86 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgeon Surgical Instrumentation, Inc. 14762 Bentley Cir., Tustin CA
510(k) summary
Statement
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

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