FDA Product Code
FDA Product Code HNY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4350
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961524 | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS | Sterilab, Inc. | 1996-05-16 | Traditional | PDF ↗ |
| K880345 | CYSTOTOMES/KNIFES | Myocure, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K874997 | PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874983 | PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K875001 | PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874975 | PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874993 | PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874976 | PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | Van Dellen, Ltd. | 1987-09-04 | Traditional | PDF ↗ |
| K871365 | CAPSULECTOMER CYSTOTOME | Noetix, Inc. | 1987-04-16 | Traditional | PDF ↗ |
| K870439 | LOOK IRRIGATING CYSTOTOMES | Look, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K862709 | MECHANICAL CYSTITOME | Rudolph Beaver, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K852934 | PRECISION - COSMET CAPSULE COUPEUR | Precision-Cosmet Co., Inc. | 1985-08-08 | Traditional | PDF ↗ |
| K841101 | CLAYMAN-PAREL CAPSULE COUPEUR | Miami Eye Technology, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K840475 | CYSTOTOME, 140-S | Cilco, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K840659 | ANTERIOR CAPSULECTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K831916 | DISPOSABLE CYSTOTOME | CooperVision, Inc. | 1983-07-12 | Traditional | PDF ↗ |
| K830040 | DISPOSABLE CYSTOTOME | Contemporary Surgical Systems, Inc. | 1983-02-07 | Traditional | PDF ↗ |
| K790244 | CYSTOTOMES | Visitec Co. | 1979-02-12 | Traditional | PDF ↗ |
Product code HNY · Class I · Ophthalmic. Data: openFDA.