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FDA 510(k)

IRRIGATOR/ASPIRATOR PROBE

K-Number: K915074 · 1992-02-05

ApplicantBiomedical Dynamics, Inc.
Decision Date1992-02-05
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRRIGATOR/ASPIRATOR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Dynamics, Inc.. It received FDA 510(k) clearance on 1992-02-05 under 510(k) number K915074. 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 IRRIGATOR/ASPIRATOR PROBE?

IRRIGATOR/ASPIRATOR PROBE is a medical device that received FDA 510(k) clearance on 1992-02-05. The listed applicant is Biomedical Dynamics, Inc.. The 510(k) number is K915074.

When did IRRIGATOR/ASPIRATOR PROBE receive FDA 510(k) clearance?

IRRIGATOR/ASPIRATOR PROBE received FDA 510(k) clearance on 1992-02-05, under 510(k) number K915074.

Who is the listed applicant for IRRIGATOR/ASPIRATOR PROBE?

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

What is the FDA product code for IRRIGATOR/ASPIRATOR PROBE?

The FDA product code for IRRIGATOR/ASPIRATOR PROBE is HMX.

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Other records listing Biomedical Dynamics, 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.

K913751PRESSURE INFUSERK911213CUFFABLEK911216INFUSABLEK911324IRRIGATION/ASPIRATION TUBING SETK904376ANEROID BLOOD PRESSURE GAUGEK890268PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION

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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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