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FDA 510(k)

NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

K-Number: K955393 · 1997-01-09

ApplicantSurgical Innovations Plc
Decision Date1997-01-09
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Plc. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K955393. 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 NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE?

NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Surgical Innovations Plc. The 510(k) number is K955393.

When did NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE receive FDA 510(k) clearance?

NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE received FDA 510(k) clearance on 1997-01-09, under 510(k) number K955393.

Who is the listed applicant for NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE?

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

What is the FDA product code for NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE?

The FDA product code for NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE is HIF.

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Other records listing Surgical Innovations Plc 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.

K123110PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301K112659SURGICAL RETRACTORSK111986LOGIC LAPAROSCOPIC INSTRUMENT SYSTEMK100109LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICEK063485LOGIC LAPAROSCOPIC SCISSORSK962193PORTLAND TROCARS

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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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