Scissors, Ophthalmic

FDA product code HNF · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic

15510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K022840Stephens Disposable ScissorsHNF · Traditional Stephens Instruments11/01/2002SE
K897093Intraocular Microscissors by Means of Gamma Radia.HNF · Traditional Microline Pentax, Inc.04/04/1990SE
K873099Manual Ophthalmic Surgical InstrumentsHNF · Traditional Alcon Laboratories09/04/1987SE
K85176813-550,13-560 Wescott Scossors (Eye)HNF · Traditional Artiberia06/20/1985SE
K822151Surgical Instruments Represent. 4 ClassHNF · Traditional Robert I. Chien & Assoc., Inc.08/19/1982SE
K821290Littauer Scissors 5 1/2HNF · Traditional Conphar, Inc.05/28/1982SE
K821286Iris Scissors Straight 4 1/2HNF · Traditional Conphar, Inc.05/28/1982SE
K811245Ophthalmic ScissorsHNF · Traditional Keeler Instruments, Inc.07/31/1981SE
K770041Scissors, Strabismus, 4 CurvedHNF · Traditional J. Sklar Mfg. Co., Inc.01/14/1977SE
K770040Scissors, Strabimus, 4 StraightHNF · Traditional J. Sklar Mfg. Co., Inc.01/14/1977SE
K770019Scissors, IrisHNF · Traditional J. Sklar Mfg. Co., Inc.01/12/1977SE
K760326Surgical Instruments, OpthalmicHNF · Traditional Depuy, Inc.08/04/1976SE
K760190Scissors, Iris StraightHNF · Traditional V. Mueller O.V. Baxter Healthcare Corp.08/04/1976SE
K760188Scissors, Micro Iris CurvedHNF · Traditional V. Mueller O.V. Baxter Healthcare Corp.08/04/1976SE
K760185Scissors, Micro Iris StraightHNF · Traditional V. Mueller O.V. Baxter Healthcare Corp.08/04/1976SE

Recalls

RecallProductFirmInitiated
Z-0950-2025 Class IIMedical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model…Reports of various packaging issues that may result in a breach of the sterile barrier. Sklar Instruments12/03/2024Open, Classified
Z-0521-2025 Class IIBrand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle…Due to pin coming off of handles. MicroSurgical Technology Inc09/17/2024Open, Classified