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FDA 510(k)

CONCEPT SUCTION SLEEVE

K-Number: K850423 · 1985-03-14

ApplicantConcept, Inc.
Decision Date1985-03-14
Product CodeHTZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONCEPT SUCTION SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1985-03-14 under 510(k) number K850423. The device is classified under product code HTZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT SUCTION SLEEVE?

CONCEPT SUCTION SLEEVE is a medical device that received FDA 510(k) clearance on 1985-03-14. The listed applicant is Concept, Inc.. The 510(k) number is K850423.

When did CONCEPT SUCTION SLEEVE receive FDA 510(k) clearance?

CONCEPT SUCTION SLEEVE received FDA 510(k) clearance on 1985-03-14, under 510(k) number K850423.

Who is the listed applicant for CONCEPT SUCTION SLEEVE?

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 CONCEPT SUCTION SLEEVE?

The FDA product code for CONCEPT SUCTION SLEEVE is HTZ.

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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: HTZ)

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.

K933933CEBOPLANESynvasive Technology, Inc.K931737HEDLEYL INTRAMEDULLARY PREPARATION BRUSHSynvasive Technology, Inc.K87088245 DEGREE SHAVERBowen & Company, Inc.K853678KAMBIN SPINAL INSTRUMENT SETPilling Co.K850527ARTHROSCOPY SUCTION BIOPSY PUNCHT. Korossurgical Instruments Corp.K841980SIDE CUTTING SERRATED BLADEStainless Mfg., Inc.

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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