510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961934Substantially Equivalent

Puritan Foam Tip Swab Model 2197

Hardwood Products Co., LP, Guilford ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961934 is the FDA 510(k) clearance record for PURITAN FOAM TIP SWAB MODEL 2197, a class II device, cleared for Hardwood Products Co., LP on under FDA product code HHT (Spatula, Cervical, Cytological). FDA records list one 510(k) clearance for Hardwood Products Co., LP. As of , FDA records show no recalls naming K961934.

Clearance record

Decision date
Received
(53 days to decision)
Product code
HHT Spatula, Cervical, Cytological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hardwood Products Co., LP P.O. Box 149, 31 School St., Guilford ME
510(k) summary
Summary
Third party review
No

Clearances, product code HHT

Trailing 12 months

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

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