BEAVER R-K KNIFE— 510(k) K852828

Name: FDA 510(k) clearance K852828
Creator: U.S. Food and Drug Administration
Published: 1985-11-04

Substantially Equivalent for Some Indications

Rudolph Beaver, Inc.

FDA 510(k) clearance K852828 for BEAVER R-K KNIFE, Substantially Equivalent for Some Indications on 1985-11-04. Applicant: Rudolph Beaver, Inc.. Device class: 1.

Clearance details

Applicant: Rudolph Beaver, Inc.
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-07-02
Decision date: 1985-11-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Rudolph Beaver, Inc.

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K883361 — ARTHRO-TRAC(TM)1988-10-13
K875030 — OCU-11988-05-03
K862709 — MECHANICAL CYSTITOME1986-08-01
K860305 — BEAVER MICRO-GEM GAUGE BLOCK1986-02-12
K853129 — BEAVER MULTIPURPOSE SAPPHIRE KNIFE1985-08-06

Adverse events under product code HNN

product code HNN

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.