Atlas FDA

HNF

15 FDA 510(k) clearances · Product code

28 daysmedian time to decision
88 days90th percentile
15clearances measured

FDA profile

Official device name
Scissors, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2019: 19 · 2021: 18 · 2022: 20 · 2023: 57 · 2024: 30 · 2025: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
STEPHENS DISPOSABLE SCISSORS (K022840)Stephens Instruments2002-11-01
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (K897093)Microline Pentax, Inc.1990-04-04
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (K873099)Alcon Laboratories1987-09-04
13-550,13-560 WESCOTT SCOSSORS (EYE) (K851768)Artiberia1985-06-20
SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (K822151)Robert I. Chien & Assoc., Inc.1982-08-19
LITTAUER SCISSORS 5 1/2 (K821290)Conphar, Inc.1982-05-28
IRIS SCISSORS STRAIGHT 4 1/2 (K821286)Conphar, Inc.1982-05-28
OPHTHALMIC SCISSORS (K811245)Keeler Instruments, Inc.1981-07-31
SCISSORS, STRABIMUS, 4 STRAIGHT (K770040)J. Sklar Mfg. Co., Inc.1977-01-14
SCISSORS, STRABISMUS, 4 CURVED (K770041)J. Sklar Mfg. Co., Inc.1977-01-14
SCISSORS, IRIS (K770019)J. Sklar Mfg. Co., Inc.1977-01-12
SCISSORS, MICRO IRIS STRAIGHT (K760185)V. Mueller O.V. Baxter Healthcare Corp.1976-08-04
SURGICAL INSTRUMENTS, OPTHALMIC (K760326)Depuy, Inc.1976-08-04
SCISSORS, MICRO IRIS CURVED (K760188)V. Mueller O.V. Baxter Healthcare Corp.1976-08-04
SCISSORS, IRIS STRAIGHT (K760190)V. Mueller O.V. Baxter Healthcare Corp.1976-08-04

Track HNF automatically

Every clearance here is in the API, with alerts when new ones post.