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FDA 510(k)

IRRIGATION/ASPIRATION NEEDLE

K-Number: K771416 · 1977-09-12

ApplicantConcept, Inc.
Decision Date1977-09-12
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRRIGATION/ASPIRATION 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 1977-09-12 under 510(k) number K771416. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION/ASPIRATION NEEDLE?

IRRIGATION/ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 1977-09-12. The listed applicant is Concept, Inc.. The 510(k) number is K771416.

When did IRRIGATION/ASPIRATION NEEDLE receive FDA 510(k) clearance?

IRRIGATION/ASPIRATION NEEDLE received FDA 510(k) clearance on 1977-09-12, under 510(k) number K771416.

Who is the listed applicant for IRRIGATION/ASPIRATION 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 IRRIGATION/ASPIRATION NEEDLE?

The FDA product code for IRRIGATION/ASPIRATION NEEDLE is HMX.

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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: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, 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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