510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823694Substantially Equivalent

Vascu-Statt Approximator

Scanlan Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823694 is the FDA 510(k) clearance record for VASCU-STATT APPROXIMATOR, a class I device, cleared for Scanlan Intl., Inc. on under FDA product code HRQ (Hemostat). FDA records list 19 510(k) clearances for Scanlan Intl., Inc., from to . As of , FDA records show no recalls naming K823694.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HRQ Hemostat
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Scanlan Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HRQ

Trailing 12 months

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

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