510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993544Substantially Equivalent

Space-or Retractor

Advanced Surgical Concepts (Asc), North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993544 is the FDA 510(k) clearance record for SPACE-OR RETRACTOR, a class I device, cleared for Advanced Surgical Concepts (Asc) on under FDA product code FFO (Retractor, Self-Retaining). FDA records list 4 510(k) clearances for Advanced Surgical Concepts (Asc), from to . As of , FDA records show no recalls naming K993544.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FFO Retractor, Self-Retaining
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Advanced Surgical Concepts (Asc) 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code FFO

Trailing 12 months

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

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