510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K897093Substantially Equivalent

Intraocular Microscissors by Means of Gamma Radia.

Microline Pentax, Inc., Devers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897093 is the FDA 510(k) clearance record for INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA., a class I device, cleared for Microline Pentax, Inc. on under FDA product code HNF (Scissors, Ophthalmic). FDA records list 12 510(k) clearances for Microline Pentax, Inc., from to . As of , FDA records show no recalls naming K897093.

Clearance record

Decision date
Received
(105 days to decision)
Product code
HNF Scissors, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Microline Pentax, Inc. 199 Newbury St., Devers MA
Third party review
No

Clearances, product code HNF

Trailing 12 months

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

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