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FDA 510(k)

TORQUE PLUS CATALOG 30120

K-Number: K833940 · 1983-12-28

ApplicantConcept, Inc.
Decision Date1983-12-28
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TORQUE PLUS CATALOG 30120 is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1983-12-28 under 510(k) number K833940. 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 TORQUE PLUS CATALOG 30120?

TORQUE PLUS CATALOG 30120 is a medical device that received FDA 510(k) clearance on 1983-12-28. The listed applicant is Concept, Inc.. The 510(k) number is K833940.

When did TORQUE PLUS CATALOG 30120 receive FDA 510(k) clearance?

TORQUE PLUS CATALOG 30120 received FDA 510(k) clearance on 1983-12-28, under 510(k) number K833940.

Who is the listed applicant for TORQUE PLUS CATALOG 30120?

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

What is the FDA product code for TORQUE PLUS CATALOG 30120?

The FDA product code for TORQUE PLUS CATALOG 30120 is HWE.

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Other records listing Concept, Inc. as applicant

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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: HWE)

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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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