Bone Lavage System

FDA 510(k) K926337 · Innovative Surgical Devices Corp.

Substantially Equivalent

510(k) numberK926337

Submission

Device name
Bone Lavage System
Applicant
Innovative Surgical Devices Corp.
Stillwater, MN, US
Received
December 17, 1992
Decision date
June 11, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FQH – Lavage, Jet
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5475
Specialty
General Hospital

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Questions and answers

When was Bone Lavage System cleared by the FDA?

Bone Lavage System (K926337) received a 510(k) decision of Substantially Equivalent on June 11, 1993, 176 days after the submission was received.

What is the product code of K926337?

The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.