FDA 510(k)

C-LOOPS

K-Number: K833856 · 1984-02-04

Decision Date1984-02-04

Product Code

DecisionSubstantially Equivalent

Device Summary

C-LOOPS is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K833856. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-LOOPS?

C-LOOPS is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Concept, Inc.. The 510(k) number is K833856.

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

C-LOOPS received FDA 510(k) clearance on 1984-02-04, under 510(k) number K833856.

Who is the listed applicant for C-LOOPS?

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

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Other records listing Concept, Inc. as applicant

K912640CONCEPT ENDOSTEAL FIXATION DEVICE K912957CONCEPT MICROMILL K896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEM K894929STAPLE FIXATION SYSTEM K892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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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.