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FDA 510(k)

DYMAX ENDOVAGINAL BIOPSY GUIDE

K-Number: K894415 · 1989-10-25

ApplicantDymax Corp
Decision Date1989-10-25
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DYMAX ENDOVAGINAL BIOPSY GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Dymax Corp. It received FDA 510(k) clearance on 1989-10-25 under 510(k) number K894415. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYMAX ENDOVAGINAL BIOPSY GUIDE?

DYMAX ENDOVAGINAL BIOPSY GUIDE is a medical device that received FDA 510(k) clearance on 1989-10-25. The listed applicant is Dymax Corp. The 510(k) number is K894415.

When did DYMAX ENDOVAGINAL BIOPSY GUIDE receive FDA 510(k) clearance?

DYMAX ENDOVAGINAL BIOPSY GUIDE received FDA 510(k) clearance on 1989-10-25, under 510(k) number K894415.

Who is the listed applicant for DYMAX ENDOVAGINAL BIOPSY GUIDE?

The FDA 510(k) record lists Dymax Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYMAX ENDOVAGINAL BIOPSY GUIDE?

The FDA product code for DYMAX ENDOVAGINAL BIOPSY GUIDE is HGL.

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Other records listing Dymax Corp 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.

K032135SITE-RITE IV ULTRASOUND SYSTEMK993624SITE-RITE 3 ULTRASOUND SYSTEMK931403SITERITE NEEDLE GUIDE (MODIFIED)K903158SITERITE NEEDLE GUIDEK862127DYMAX PERSONAL SCANNERK850478PLUS 1

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Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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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