Product code HNY— Ophthalmic
DISPOSABLE CYSTOTOME
- Classification name
- Cystotome
- Device class
- Class 1
- Regulation
- 21 CFR 886.4350
- Advisory panel
- Ophthalmic
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code HNY
FDA has cleared devices under product code HNY between 1979 and 1996, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1979
Top applicants under product code HNY
Recent clearances under product code HNY
- K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
- K880345 — CYSTOTOMES/KNIFES
- K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME
- K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
- K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
- K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
- K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
- K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
- K873163 — VAN DELLEN IRRIGATING CYSTOTOME
- K871365 — CAPSULECTOMER CYSTOTOME
- K870439 — LOOK IRRIGATING CYSTOTOMES
- K862709 — MECHANICAL CYSTITOME
- K852934 — PRECISION - COSMET CAPSULE COUPEUR
- K841101 — CLAYMAN-PAREL CAPSULE COUPEUR
- K840475 — CYSTOTOME, 140-S
- K840659 — ANTERIOR CAPSULECTOMY CYSTITOME
- K840660 — POSTERIOR CAPSULOTOMY CYSTITOME
- K831916 — DISPOSABLE CYSTOTOME
- K830040 — DISPOSABLE CYSTOTOME
- K790244 — CYSTOTOMES
Data sourced from openFDA. This site is unofficial and independent of the FDA.