510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011514Substantially Equivalent

Instruments for One Time Use - Disposable

Kencap Ltd., Ringwood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011514 is the FDA 510(k) clearance record for INSTRUMENTS FOR ONE TIME USE - DISPOSABLE, a class I device, cleared for Kencap , Ltd. on under FDA product code KDD (Kit, Surgical Instrument, Disposable). FDA records list one 510(k) clearance for Kencap , Ltd. As of , FDA records show no recalls naming K011514.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KDD Kit, Surgical Instrument, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kencap , Ltd. 247 Margaret King Ave., Ringwood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code KDD

Trailing 12 months

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

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