FDA product code HNF: Scissors, Ophthalmic
HNF is the FDA product code for scissors, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 15 510(k) submissions under HNF, from 10 different applicants. The average 510(k) review took 35 days (median 28). FDA has posted 2 recalls for HNF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HNF clearance
Top HNF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. Sklar Mfg. Co., Inc. | 3 | 1977-01-14 |
| V. Mueller O.V. Baxter Healthcare Corp. | 3 | 1976-08-04 |
| Conphar, Inc. | 2 | 1982-05-28 |
| Stephens Instruments | 1 | 2002-11-01 |
| Microline Pentax, Inc. | 1 | 1990-04-04 |
5 more applicants have HNF clearances. See the full list in Caduvo.
Most recent HNF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022840 | Stephens Instruments | STEPHENS DISPOSABLE SCISSORS | 2002-11-01 | 66 |
| K897093 | Microline Pentax, Inc. | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. | 1990-04-04 | 105 |
| K873099 | Alcon Laboratories | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | 1987-09-04 | 28 |
| K851768 | Artiberia | 13-550,13-560 WESCOTT SCOSSORS (EYE) | 1985-06-20 | 56 |
| K822151 | Robert I. Chien & Assoc., Inc. | SURGICAL INSTRUMENTS REPRESENT. 4 CLASS | 1982-08-19 | 28 |
Recalls for HNF devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code HNF?
HNF is the FDA product code for scissors, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNF?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNF?
Across 15 cleared submissions the average was 35 days from receipt to decision (median 28).
Which companies have the most HNF clearances?
J. Sklar Mfg. Co., Inc. (3); V. Mueller O.V. Baxter Healthcare Corp. (3); Conphar, Inc. (2); Stephens Instruments (1); Microline Pentax, Inc. (1).
Have HNF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HNF
- Run a recall and safety report across every HNF manufacturer
- Watch product code HNF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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