RICHARDS INTRA-ARTICULAR SHAVER BLADES— 510(k) K830153

Name: FDA 510(k) clearance K830153
Creator: U.S. Food and Drug Administration
Published: 1983-02-28

Substantially Equivalent

Richard'S Medical Equip., Inc.

FDA 510(k) clearance K830153 for RICHARDS INTRA-ARTICULAR SHAVER BLADES, Substantially Equivalent on 1983-02-28. Applicant: Richard'S Medical Equip., Inc.. Device class: 1.

Clearance details

Applicant: Richard'S Medical Equip., Inc.
Product code: Code GEY
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1983-01-18
Decision date: 1983-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS)2001-11-14
K972308 — MEDNEXT 1000 DRILL1997-08-20
K971941 — AQUA SPRAY1997-08-14

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K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC1983-06-16
K823837 — RMC TOTAL KNEE SYSTEM1983-03-29
K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS1983-03-09
K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS1983-03-09
K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP1983-03-09

Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.