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FDA 510(k)

OTT INSUFFLATION FILTER TUBING

K-Number: K900878 · 1990-05-07

ApplicantGynescope Corp.
Decision Date1990-05-07
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OTT INSUFFLATION FILTER TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Gynescope Corp.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K900878. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTT INSUFFLATION FILTER TUBING?

OTT INSUFFLATION FILTER TUBING is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Gynescope Corp.. The 510(k) number is K900878.

When did OTT INSUFFLATION FILTER TUBING receive FDA 510(k) clearance?

OTT INSUFFLATION FILTER TUBING received FDA 510(k) clearance on 1990-05-07, under 510(k) number K900878.

Who is the listed applicant for OTT INSUFFLATION FILTER TUBING?

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

What is the FDA product code for OTT INSUFFLATION FILTER TUBING?

The FDA product code for OTT INSUFFLATION FILTER TUBING is HIF.

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Other records listing Gynescope 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.

K902658GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODESK902657GYNESCOPE LAPAROSCOPIC FORCEPSK901530WALLACE INTRAUTERINE INSEMINATION CATHETERK902655GYNESCOPE LAPAROSCOPESK902656GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVESK902049CROAK OVARIAN BIOPSY FORCEP

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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