510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070596Substantially Equivalent

Topical Applicator

Sharn, Inc., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070596 is the FDA 510(k) clearance record for TOPICAL APPLICATOR, a class II device, cleared for Sharn, Inc. on under FDA product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia). FDA records list one 510(k) clearance for Sharn, Inc. As of , FDA records show 3 recalls naming K070596.

Clearance record

Decision date
Received
(111 days to decision)
Product code
CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Regulation
21 CFR 868.5170
Device class
Class II
Review panel
Anesthesiology
Applicant
Sharn, Inc. 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCT

Trailing 12 months

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

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