Product code HNY
- Device name
- Cystotome
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961524 | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS | Sterilab, Inc. | 1996-05-16 |
| K880345 | CYSTOTOMES/KNIFES | Myocure, Inc. | 1988-05-03 |
| K875001 | PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874997 | PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874993 | PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874983 | PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874976 | PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874975 | PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | Van Dellen, Ltd. | 1987-09-04 |
| K871365 | CAPSULECTOMER CYSTOTOME | Noetix, Inc. | 1987-04-16 |
| K870439 | LOOK IRRIGATING CYSTOTOMES | Look, Inc. | 1987-02-20 |
| K862709 | MECHANICAL CYSTITOME | Rudolph Beaver, Inc. | 1986-08-01 |
| K852934 | PRECISION - COSMET CAPSULE COUPEUR | Precision-Cosmet Co., Inc. | 1985-08-08 |
| K841101 | CLAYMAN-PAREL CAPSULE COUPEUR | Miami Eye Technology, Inc. | 1984-05-16 |
| K840475 | CYSTOTOME, 140-S | Cilco, Inc. | 1984-04-05 |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 |
| K840659 | ANTERIOR CAPSULECTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 |
| K831916 | DISPOSABLE CYSTOTOME | CooperVision, Inc. | 1983-07-12 |
| K830040 | DISPOSABLE CYSTOTOME | Contemporary Surgical Systems, Inc. | 1983-02-07 |
| K790244 | CYSTOTOMES | Visitec Co. | 1979-02-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08052276012937 | Irrigating Cystotome Formed 27G x 16mm | AKTIVE SRL | 2023-12-19 |
| 08052276012968 | Irrigating Cystotome Ang.45° 25G x16 mm | AKTIVE SRL | 2023-12-19 |
| 08052276012432 | Irrigating Cystotome Ang.45° 27Gx16mm | AKTIVE SRL | 2023-12-19 |
| 10888277804029 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 30886158003244 | Visitec® | Beaver-Visitec International, Inc. | 2022-01-20 |
| 30886158003220 | Visitec® | Beaver-Visitec International, Inc. | 2022-01-20 |
| 30886158003213 | Visitec® | Beaver-Visitec International, Inc. | 2022-01-20 |
| 30886158101322 | Visitec® | Beaver-Visitec International, Inc. | 2021-11-01 |
| 30886158101285 | Visitec® | Beaver-Visitec International, Inc. | 2021-11-01 |
| 30886158101209 | Visitec® | Beaver-Visitec International, Inc. | 2021-11-01 |
| 30886158101193 | Visitec® | Beaver-Visitec International, Inc. | 2021-11-01 |
| 30886158006504 | Visitec® | Beaver-Visitec International, Inc. | 2021-11-01 |
| 10190660199040 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199033 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660198906 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198913 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198920 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198937 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198968 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198982 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198999 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660199002 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660199026 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660199064 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10811313012294 | MedOne | MEDONE SURGICAL INC | 2020-05-08 |
| 10811313012041 | MedOne | MEDONE SURGICAL INC | 2020-05-08 |
| 10381780405559 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780362951 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780405542 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780362937 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |