510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920643Substantially Equivalent

Laparoscopic Suction/irrigation Probe

O.R. Concepts, Inc., Roanoke TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920643 is the FDA 510(k) clearance record for LAPAROSCOPIC SUCTION/IRRIGATION PROBE, a class I device, cleared for O.R. Concepts, Inc. on under FDA product code GBZ (Catheter, Cholangiography). FDA records list 34 510(k) clearances for O.R. Concepts, Inc., from to . As of , FDA records show no recalls naming K920643.

Clearance record

Decision date
Received
(84 days to decision)
Product code
GBZ Catheter, Cholangiography
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
O.R. Concepts, Inc. 200 N. Oak St., Roanoke TX
510(k) summary
Statement
Third party review
No

Clearances, product code GBZ

Trailing 12 months

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

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