510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945480Substantially Equivalent

Moss(r) Steel Breakaway(r) Introducer

Harry A. Schlakman, Elizabeth NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945480 is the FDA 510(k) clearance record for MOSS(R) STEEL BREAKAWAY(R) INTRODUCER, a class II device, cleared for Harry A. Schlakman on under FDA product code KOB (Catheter, Suprapubic (And Accessories)). FDA records list 2 510(k) clearances for Harry A. Schlakman, from to . As of , FDA records show no recalls naming K945480.

Clearance record

Decision date
Received
(293 days to decision)
Product code
KOB Catheter, Suprapubic (And Accessories)
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Harry A. Schlakman 301 Verona Ave., Elizabeth NJ
510(k) summary
Statement
Third party review
No

Clearances, product code KOB

Trailing 12 months

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

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