510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K911462Substantially Equivalent

Surgical Trocar

Applied Medical, Bolton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911462 is the FDA 510(k) clearance record for SURGICAL TROCAR, a class II device, cleared for Applied Medical on under FDA product code DRC (Trocar). FDA records list 14 510(k) clearances for Applied Medical, from to . As of , FDA records show 2 recalls naming K911462.

Clearance record

Decision date
Received
(19 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Applicant
Applied Medical 93 Nashaway Rd., Bolton MA
Third party review
No

Clearances, product code DRC

Trailing 12 months

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

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