510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020500Substantially Equivalent

Univec Bifurcated Sliding Sheath Syringe

Univec, Inc., Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020500 is the FDA 510(k) clearance record for UNIVEC BIFURCATED SLIDING SHEATH SYRINGE, a class II device, cleared for Univec, Inc. on under FDA product code SCL (Allergen And Vaccine Delivery Needles). FDA's definition for product code SCL reads: "An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests". FDA records list 7 510(k) clearances for Univec, Inc., from to . As of , FDA records show no recalls naming K020500.

Clearance record

Decision date
Received
(33 days to decision)
Product code
SCL Allergen And Vaccine Delivery Needles
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Univec, Inc. 22 Dubon Ct., Farmingdale NY
510(k) summary
Statement
Third party review
No

Clearances, product code SCL

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