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FDA 510(k)

GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP

K-Number: K852357 · 1985-07-05

ApplicantGyneco, Inc.
Decision Date1985-07-05
Product CodeHFB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP is the device name listed in this FDA 510(k) record. The listed applicant is Gyneco, Inc.. It received FDA 510(k) clearance on 1985-07-05 under 510(k) number K852357. The device is classified under product code HFB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP?

GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP is a medical device that received FDA 510(k) clearance on 1985-07-05. The listed applicant is Gyneco, Inc.. The 510(k) number is K852357.

When did GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP receive FDA 510(k) clearance?

GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP received FDA 510(k) clearance on 1985-07-05, under 510(k) number K852357.

Who is the listed applicant for GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP?

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

What is the FDA product code for GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP?

The FDA product code for GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP is HFB.

Related Clinical Trials

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Other records listing Gyneco, 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.

K861409SYNCARE TEMPORARY CARDIAC PACING WIREK853216MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4K843941ENDOCYTEK841275FINE NEEDLE ASPIRATION DEVICE

Related Devices (Code: HFB)

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.

K011488SPIRABRUSH CX BIOPSY INSTRUMENTTrylon Corp.K944444CIT BIOPSY PUNCHESChirurgische InstrumenteK930773SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPSSymbiosis Corp.K933767FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSYMahe-MedizintechnikK926595OWENS BIOPSY FORCEPSOwens Industries, Inc.K926527ROTO FIT BIOPSY FORCEPSThomasville Medical Assoc.

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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