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FDA 510(k)

C-BLADE

K-Number: K802105 · 1980-09-16

ApplicantCutter Laboratories, Inc.
Decision Date1980-09-16
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C-BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802105. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-BLADE?

C-BLADE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K802105.

When did C-BLADE receive FDA 510(k) clearance?

C-BLADE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802105.

Who is the listed applicant for C-BLADE?

The FDA 510(k) record lists Cutter Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-BLADE?

The FDA product code for C-BLADE is HWE.

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Other records listing Cutter Laboratories, Inc. as applicant

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K861315HYPERBARIC PENETRATION EXTENSION SETK854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK832237ORTHOPEDIC CASTING TAPE MAXCASTK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SET

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Related Devices (Code: HWE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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