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FDA 510(k)

OTT INSUFFLATOR FILTER PLUS/TUBING SET

K-Number: K914153 · 1992-04-02

ApplicantMarlo Surgical Technology
Decision Date1992-04-02
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OTT INSUFFLATOR FILTER PLUS/TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Marlo Surgical Technology. It received FDA 510(k) clearance on 1992-04-02 under 510(k) number K914153. 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 INSUFFLATOR FILTER PLUS/TUBING SET?

OTT INSUFFLATOR FILTER PLUS/TUBING SET is a medical device that received FDA 510(k) clearance on 1992-04-02. The listed applicant is Marlo Surgical Technology. The 510(k) number is K914153.

When did OTT INSUFFLATOR FILTER PLUS/TUBING SET receive FDA 510(k) clearance?

OTT INSUFFLATOR FILTER PLUS/TUBING SET received FDA 510(k) clearance on 1992-04-02, under 510(k) number K914153.

Who is the listed applicant for OTT INSUFFLATOR FILTER PLUS/TUBING SET?

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

What is the FDA product code for OTT INSUFFLATOR FILTER PLUS/TUBING SET?

The FDA product code for OTT INSUFFLATOR FILTER PLUS/TUBING SET is HIF.

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Other records listing Marlo Surgical Technology 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.

K960810BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MMK962273MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NSTK924611IRRIGATION PUMP AND TUBING SETK932832PRIMUS INSULATED FORCEPSK932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURESK920611MARLOW LAPAROSCOPIC GRASPING 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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