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FDA 510(k)

ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)

K-Number: K970873 · 1997-05-20

ApplicantAmerican Medical Devices, Inc.
Decision Date1997-05-20
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Devices, Inc.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K970873. 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 ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)?

ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is American Medical Devices, Inc.. The 510(k) number is K970873.

When did ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) receive FDA 510(k) clearance?

ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) received FDA 510(k) clearance on 1997-05-20, under 510(k) number K970873.

Who is the listed applicant for ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)?

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

What is the FDA product code for ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)?

The FDA product code for ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) is HMX.

Related Clinical Trials

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Other records listing American Medical Devices, 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.

K974561MOISTAIR FLUID AIR TUBING SETK971853ENDOVIEW SPPHIRE LENS SETK970882ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)K970875ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)K970878ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT

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.ComK943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, Inc.K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEKirwan Surgical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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