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
K935531Substantially Equivalent

Op-Flex Sump Suction Set with Diffuser Tip

Puritas Health Care, Inc., New Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935531 is the FDA 510(k) clearance record for OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP, a class I device, cleared for Puritas Health Care, Inc. on under FDA product code GBX (Catheter, Irrigation). FDA records list 24 510(k) clearances for Puritas Health Care, Inc., from to . As of , FDA records show no recalls naming K935531.

Clearance record

Decision date
Received
(170 days to decision)
Product code
GBX Catheter, Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Puritas Health Care, Inc. 219 Kent Rd.,, New Milford CT
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