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FDA 510(k)

ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION

K-Number: K921488 · 1992-05-07

ApplicantSurgical Technologies, Inc.
Decision Date1992-05-07
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1992-05-07 under 510(k) number K921488. 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 ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION?

ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION is a medical device that received FDA 510(k) clearance on 1992-05-07. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K921488.

When did ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION receive FDA 510(k) clearance?

ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION received FDA 510(k) clearance on 1992-05-07, under 510(k) number K921488.

Who is the listed applicant for ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION?

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

What is the FDA product code for ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION?

The FDA product code for ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION is HMX.

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Other records listing Surgical Technologies, 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.

K941992CYSTOSCOPEK942029ARTHROSCOPEK946136INFINITECH LIGHTED INFUSION CANNULAK952566OSCILFLATORK951918SURGICAL TECHNOLOGIES, INC. SYRINGEK950683ARTHROGRAM TRAY

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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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