510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K942064Substantially Equivalent

Disposable Nasal Rongeur

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942064 is the FDA 510(k) clearance record for DISPOSABLE NASAL RONGEUR, a class I device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code LRC (Instrument, Ent Manual Surgical). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K942064.

Clearance record

Decision date
Received
(40 days to decision)
Product code
LRC Instrument, Ent Manual Surgical
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code LRC

Trailing 12 months

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

FDA records show no clearances under product code LRC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260