FDA product code HNY: Cystotome
HNY is the FDA product code for cystotome. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 20 510(k) submissions under HNY, from 14 different applicants. The average 510(k) review took 65 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Cystotome |
| 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 HNY clearance
Top HNY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Surgical Products, Inc. | 6 | 1988-04-13 |
| Sharpoint, Inc. | 2 | 1984-03-16 |
| Sterilab, Inc. | 1 | 1996-05-16 |
| Myocure, Inc. | 1 | 1988-05-03 |
| Van Dellen, Ltd. | 1 | 1987-09-04 |
9 more applicants have HNY clearances. See the full list in Caduvo.
Most recent HNY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961524 | Sterilab, Inc. | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS | 1996-05-16 | 24 |
| K880345 | Myocure, Inc. | CYSTOTOMES/KNIFES | 1988-05-03 | 98 |
| K874997 | Advanced Surgical Products, Inc. | PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME | 1988-04-13 | 133 |
| K874976 | Advanced Surgical Products, Inc. | PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME | 1988-04-13 | 133 |
| K875001 | Advanced Surgical Products, Inc. | PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME | 1988-04-13 | 131 |
Recalls for HNY devices
openFDA lists no recalls for product code HNY.
Frequently asked questions
What is FDA product code HNY?
HNY is the FDA product code for cystotome. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNY?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNY?
Across 20 cleared submissions the average was 65 days from receipt to decision (median 38).
Which companies have the most HNY clearances?
Advanced Surgical Products, Inc. (6); Sharpoint, Inc. (2); Sterilab, Inc. (1); Myocure, Inc. (1); Van Dellen, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HNY
- Run a recall and safety report across every HNY manufacturer
- Watch product code HNY 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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