510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944640Substantially Equivalent

Laparoscopic Surgical Instrument/accessory Kit

Gabris Surgical Corp., Virginia Beach VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944640 is the FDA 510(k) clearance record for LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT, a class II device, cleared for Gabris Surgical Corp. on under FDA product code FBQ (Trocar, Gastro-Urology). FDA records list 7 510(k) clearances for Gabris Surgical Corp., from to . As of , FDA records show no recalls naming K944640.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FBQ Trocar, Gastro-Urology
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gabris Surgical Corp. 1432 N. Great Neck Rd.,, Virginia Beach VA
510(k) summary
Statement
Third party review
No

Clearances, product code FBQ

Trailing 12 months

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

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