510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K933569Substantially Equivalent

Pent Nova Autoblock Syringe

Medi-Hut Co., Inc., Washington D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933569 is the FDA 510(k) clearance record for PENT NOVA AUTOBLOCK SYRINGE, a class II device, cleared for Medi-Hut Co., Inc. on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Medi-Hut Co., Inc. As of , FDA records show no recalls naming K933569.

Clearance record

Decision date
Received
(687 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Medi-Hut Co., Inc. 1333 New Hampshire Ave.,NW, Washington D.C. DC
510(k) summary
Statement
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260