510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K921095Substantially Equivalent

Pacer Disposable Yankauer Suction Instrument

Pacer Tool & Plastics, Inc., South Plainfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921095 is the FDA 510(k) clearance record for PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT, a class I device, cleared for Pacer Tool & Plastics, Inc. on under FDA product code GBX (Catheter, Irrigation). FDA records list one 510(k) clearance for Pacer Tool & Plastics, Inc. As of , FDA records show no recalls naming K921095.

Clearance record

Decision date
Received
(54 days to decision)
Product code
GBX Catheter, Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pacer Tool & Plastics, Inc. 660 Montrose Ave., South Plainfield NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GBX

Trailing 12 months

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

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