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FDA 510(k)

LASER SPECULA

K-Number: K891044 · 1989-03-17

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-03-17
Product CodeHDF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LASER SPECULA 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 1989-03-17 under 510(k) number K891044. The device is classified under product code HDF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER SPECULA?

LASER SPECULA is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891044.

When did LASER SPECULA receive FDA 510(k) clearance?

LASER SPECULA received FDA 510(k) clearance on 1989-03-17, under 510(k) number K891044.

Who is the listed applicant for LASER SPECULA?

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 LASER SPECULA?

The FDA product code for LASER SPECULA is HDF.

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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: HDF)

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.

K926429VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTThomasville Medical Assoc.K902019MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPSGynescope Corp.K891041MIYA SPECULUMZinnanti Surgical Instruments, Inc.K890375VAGINAL SPECULUMKinetic Medical ProductsK862478HAYES VAGINAL SHIELDFranklin Medical USA, Inc.K853640WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINALDowns Surgical , Ltd.

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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