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FDA 510(k)

X-PAK

K-Number: K791917 · 1979-10-30

ApplicantContemporary Surgical Systems, Inc.
Decision Date1979-10-30
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

X-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Contemporary Surgical Systems, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K791917. 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 X-PAK?

X-PAK is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Contemporary Surgical Systems, Inc.. The 510(k) number is K791917.

When did X-PAK receive FDA 510(k) clearance?

X-PAK received FDA 510(k) clearance on 1979-10-30, under 510(k) number K791917.

Who is the listed applicant for X-PAK?

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

What is the FDA product code for X-PAK?

The FDA product code for X-PAK is HMX.

Other records listing Contemporary Surgical Systems, 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.

K830040DISPOSABLE CYSTOTOMEK800110X-FLO

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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