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FDA 510(k)

ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER

K-Number: K943954 · 1994-11-15

ApplicantConmedcorp
Decision Date1994-11-15
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Conmedcorp. It received FDA 510(k) clearance on 1994-11-15 under 510(k) number K943954. 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 ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER?

ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is Conmedcorp. The 510(k) number is K943954.

When did ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER receive FDA 510(k) clearance?

ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER received FDA 510(k) clearance on 1994-11-15, under 510(k) number K943954.

Who is the listed applicant for ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER?

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

What is the FDA product code for ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER?

The FDA product code for ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER is HIF.

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Other records listing Conmedcorp 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.

K101534CONMED ALTRUS THERMAL TISSUE FUSION SYSTEMK061021ENTAKE STANDARD AND SAFETY PEG SYSTEMK050992CONMED IRRIGATION NOZZLEK050777PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907K050304FX WIRE ADVANCED MEASUREMENT GUIDEWIREK041953VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART

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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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