MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT— 510(k) K902818

Name: FDA 510(k) clearance K902818
Creator: U.S. Food and Drug Administration
Published: 1990-09-20

Substantially Equivalent

Ruggles Corp.

FDA 510(k) clearance K902818 for MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT, Substantially Equivalent on 1990-09-20. Applicant: Ruggles Corp.. Device class: 2.

Clearance details

Applicant: Ruggles Corp.
Product code: Code HBG
Device class: Class 2
Regulation: 21 CFR 882.4300
Advisory panel: Neurology
Date received: 1990-06-27
Decision date: 1990-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: No. Quincy, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ruggles Corp.

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K903485 — TITANIUM MESH1991-02-21
K902819 — LAMINECTOMY ROGEUR1990-08-09
K902850 — ZEPPELIN INSTRUMENTS1990-07-18
K893415 — TRANS-ORAL DEPTH GAUGE1989-06-07

Recalls naming K902818

K-number listed on FDA's recall record

Z-2056-2013 — Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.Class II·Terminated·Integra Limited·20130717

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902818.

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