510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951702Substantially Equivalent for Some Indications

Fms High Flow Arthro-Sheath

Future Medical Systems, Inc., New York City NY / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K951702 is the FDA 510(k) clearance record for FMS HIGH FLOW ARTHRO-SHEATH, a class I device, cleared for Future Medical Systems, Inc. on under FDA product code HNX (Depressor, Orbital). FDA records list 14 510(k) clearances for Future Medical Systems, Inc., from to . As of , FDA records show no recalls naming K951702.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HNX Depressor, Orbital
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Future Medical Systems, Inc. 205 E. 63rd St., New York City NY
Third party review
No

Clearances, product code HNX

Trailing 12 months

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

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