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FDA 510(k)

ROTO FIT BIOPSY FORCEPS

K-Number: K891043 · 1989-03-22

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-03-22
Product CodeHFB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROTO FIT BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K891043. 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 ROTO FIT BIOPSY FORCEPS?

ROTO FIT BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891043.

When did ROTO FIT BIOPSY FORCEPS receive FDA 510(k) clearance?

ROTO FIT BIOPSY FORCEPS received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891043.

Who is the listed applicant for ROTO FIT BIOPSY FORCEPS?

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

What is the FDA product code for ROTO FIT BIOPSY FORCEPS?

The FDA product code for ROTO FIT BIOPSY FORCEPS is HFB.

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Other records listing Zinnanti Surgical Instruments, 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.

K925501NYLON COATED SPECULAK941458UTERINE MANIPULATOR/INJECTOR WITH SPRINGK941457UTERINE INJECTOR WITH SPRINGK925560ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODESK925957SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEK925960FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE

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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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