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FDA 510(k)

GILL'S IRRIGATOR/ASPIRATOR NEEDLE

K-Number: K843925 · 1984-11-05

ApplicantConcept, Inc.
Decision Date1984-11-05
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GILL'S IRRIGATOR/ASPIRATOR NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1984-11-05 under 510(k) number K843925. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILL'S IRRIGATOR/ASPIRATOR NEEDLE?

GILL'S IRRIGATOR/ASPIRATOR NEEDLE is a medical device that received FDA 510(k) clearance on 1984-11-05. The listed applicant is Concept, Inc.. The 510(k) number is K843925.

When did GILL'S IRRIGATOR/ASPIRATOR NEEDLE receive FDA 510(k) clearance?

GILL'S IRRIGATOR/ASPIRATOR NEEDLE received FDA 510(k) clearance on 1984-11-05, under 510(k) number K843925.

Who is the listed applicant for GILL'S IRRIGATOR/ASPIRATOR NEEDLE?

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 GILL'S IRRIGATOR/ASPIRATOR NEEDLE?

The FDA product code for GILL'S IRRIGATOR/ASPIRATOR NEEDLE is GAA.

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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: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, 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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