510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933268Substantially Equivalent

Candela Guidewire

Candela Corporation, Wayland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933268 is the FDA 510(k) clearance record for CANDELA GUIDEWIRE, a class II device, cleared for Candela Laser Corp. on under FDA product code NWU (Endoscope Introducer Kit). FDA's definition for product code NWU reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under...". FDA records list 99 510(k) clearances for Candela Corporation, from to . As of , FDA records show no recalls naming K933268.

Clearance record

Decision date
Received
(219 days to decision)
Product code
NWU Endoscope Introducer Kit
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Candela Laser Corp. 530 Boston Post Rd., Wayland MA
510(k) summary
Summary
Third party review
No

Clearances, product code NWU

Trailing 12 months

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

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