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
K935643Substantially Equivalent

Syrigene Acetic Acid Pre-Filledsyringe

Regulatory & Marketing Services, Inc., Palm Florida FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935643 is the FDA 510(k) clearance record for SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE, a class II device, cleared for Regulatory & Marketing Services, Inc. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 22 510(k) clearances for Regulatory & Marketing Services, Inc., from to . As of , FDA records show no recalls naming K935643.

Clearance record

Decision date
Received
(196 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Regulatory & Marketing Services, Inc. P.O. Box 2010, Palm Florida FL
510(k) summary
Statement
Third party review
No

Clearances, product code KNY

Trailing 12 months
1 clearance under product code KNY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260