510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082995Substantially Equivalent

Smart Dilator

Safestitch Medical, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082995 is the FDA 510(k) clearance record for SMART DILATOR, a class II device, cleared for Safestitch Medical on under FDA product code KNQ (Dilator, Esophageal). FDA records list one 510(k) clearance for Safestitch Medical. As of , FDA records show no recalls naming K082995.

Clearance record

Decision date
Received
(121 days to decision)
Product code
KNQ Dilator, Esophageal
Regulation
21 CFR 876.5365
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Safestitch Medical 4400 Biscayne Blvd., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNQ

Trailing 12 months

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

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