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FDA 510(k)

KIRWAN IRRIGATION/ASPIRATION HANDPIECE

K-Number: K930113 · 1994-02-17

ApplicantKirwan Surgical Products, Inc.
Decision Date1994-02-17
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KIRWAN IRRIGATION/ASPIRATION HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Kirwan Surgical Products, Inc.. It received FDA 510(k) clearance on 1994-02-17 under 510(k) number K930113. 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 KIRWAN IRRIGATION/ASPIRATION HANDPIECE?

KIRWAN IRRIGATION/ASPIRATION HANDPIECE is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is Kirwan Surgical Products, Inc.. The 510(k) number is K930113.

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

KIRWAN IRRIGATION/ASPIRATION HANDPIECE received FDA 510(k) clearance on 1994-02-17, under 510(k) number K930113.

Who is the listed applicant for KIRWAN IRRIGATION/ASPIRATION HANDPIECE?

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

What is the FDA product code for KIRWAN IRRIGATION/ASPIRATION HANDPIECE?

The FDA product code for KIRWAN IRRIGATION/ASPIRATION HANDPIECE is HMX.

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Other records listing Kirwan Surgical Products, 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.

K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDEK070360KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601K060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERSK062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESK052203AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600K023482AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500

View all 18 devices →

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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