510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951519Substantially Equivalent

Weco Endoscopic System with Fiber Optic Light

Wells Johnson Co., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951519 is the FDA 510(k) clearance record for WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT, a class I device, cleared for Wells Johnson Co. on under FDA product code FWL (Camera, Cine, Endoscopic, Without Audio). FDA records list 15 510(k) clearances for Wells Johnson Co., from to . As of , FDA records show no recalls naming K951519.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FWL Camera, Cine, Endoscopic, Without Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Wells Johnson Co. 8075 E Research Ct., Suite 101, Tucson AZ
510(k) summary
Statement
Third party review
No

Clearances, product code FWL

Trailing 12 months

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

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