RUBY KNIVES FOR OPHTH. SURGERY— 510(k) K832844

Clearance details

Applicant

Keeler Instruments, Inc.

Product code

Code HNN

Device class

Class 1

Regulation

21 CFR 886.4350

Advisory panel

Ophthalmic

Date received

1983-08-22

Decision date

1983-09-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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• K922378 — OPHTHALMIC KNIFE1992-12-10
• K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE1988-08-22
• K881669 — MVR/STILETTO BLADE 20GA. - P/N 19001988-05-13
• K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE1988-04-13

• K181143 — Keeler TonoCare Tonometer2019-02-08
• K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER2011-12-08
• K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-20002010-12-10
• K100500 — PSL CLASSIC SLIT LAMP2010-03-09
• K062412 — CRYOMATIC2006-11-06

Injury

183

Malfunction

4,106

Total

4,289

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →