510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936038Substantially Equivalent

Slt Laser Continuous Flow Tesectoscope (CFR)

Surgical Laser Technologies, Inc., Oaks PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936038 is the FDA 510(k) clearance record for SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR), a class II device, cleared for Surgical Laser Technologies, Inc. on under FDA product code FJL (Resectoscope). FDA records list 51 510(k) clearances for Surgical Laser Technologies, Inc., from to . As of , FDA records show no recalls naming K936038.

Clearance record

Decision date
Received
(158 days to decision)
Product code
FJL Resectoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgical Laser Technologies, Inc. 200 Cresson Blvd., Oaks PA
510(k) summary
Statement
Third party review
No

Clearances, product code FJL

Trailing 12 months

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

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